Multi-event June 2015 FDA Recall Drug by The Compounding Pharmacy Of America

This Multi-event Class II drug recall was voluntarily initiated by The Compounding Pharmacy Of America on June 2, 2015 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; fda inspection identified gmp violations potentially impacting product quality and sterility. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1433-2015 TERMINATED D-1708-2015 TERMINATED D-1703-2015 TERMINATED D-1572-2015 TERMINATED D-1509-2015 TERMINATED D-1494-2015 TERMINATED D-1454-2015 TERMINATED D-1606-2015 TERMINATED D-1738-2015 TERMINATED D-1592-2015 TERMINATED D-1797-2015 TERMINATED D-1594-2015 TERMINATED D-1619-2015 TERMINATED D-1686-2015 TERMINATED D-1772-2015 TERMINATED D-1500-2015 TERMINATED D-1522-2015 TERMINATED D-1662-2015 TERMINATED D-1569-2015 TERMINATED D-1444-2015 TERMINATED D-1809-2015 TERMINATED D-1808-2015 TERMINATED D-1787-2015 TERMINATED D-1561-2015 TERMINATED D-1789-2015 TERMINATED D-1699-2015 TERMINATED D-1754-2015 TERMINATED D-1448-2015 TERMINATED D-1700-2015 TERMINATED D-1601-2015 TERMINATED D-1603-2015 TERMINATED D-1641-2015 TERMINATED D-1507-2015 TERMINATED D-1531-2015 TERMINATED D-1752-2015 TERMINATED D-1581-2015 TERMINATED D-1548-2015 TERMINATED D-1697-2015 TERMINATED D-1742-2015 TERMINATED D-1668-2015 TERMINATED D-1638-2015 TERMINATED D-1532-2015 TERMINATED D-1634-2015 TERMINATED D-1648-2015 TERMINATED D-1804-2015 TERMINATED D-1583-2015 TERMINATED D-1489-2015 TERMINATED D-1502-2015 TERMINATED D-1736-2015 TERMINATED D-1655-2015 TERMINATED D-1495-2015 TERMINATED D-1471-2015 TERMINATED D-1652-2015 TERMINATED D-1439-2015 TERMINATED D-1661-2015 TERMINATED D-1770-2015 TERMINATED D-1765-2015 TERMINATED D-1653-2015 TERMINATED D-1745-2015 TERMINATED D-1650-2015 TERMINATED D-1566-2015 TERMINATED D-1750-2015 TERMINATED D-1499-2015 TERMINATED D-1481-2015 TERMINATED D-1440-2015 TERMINATED D-1517-2015 TERMINATED D-1544-2015 TERMINATED D-1585-2015 TERMINATED D-1776-2015 TERMINATED D-1455-2015 TERMINATED D-1659-2015 TERMINATED D-1678-2015 TERMINATED D-1625-2015 TERMINATED D-1551-2015 TERMINATED D-1792-2015 TERMINATED D-1505-2015 TERMINATED D-1768-2015 TERMINATED D-1558-2015 TERMINATED D-1602-2015 TERMINATED D-1613-2015 TERMINATED D-1456-2015 TERMINATED D-1759-2015 TERMINATED D-1475-2015 TERMINATED D-1812-2015 TERMINATED D-1632-2015 TERMINATED D-1477-2015 TERMINATED D-1597-2015 TERMINATED D-1747-2015 TERMINATED D-1730-2015 TERMINATED D-1712-2015 TERMINATED D-1783-2015 TERMINATED D-1464-2015 TERMINATED D-1664-2015 TERMINATED D-1635-2015 TERMINATED D-1445-2015 TERMINATED D-1479-2015 TERMINATED D-1529-2015 TERMINATED D-1628-2015 TERMINATED D-1563-2015 TERMINATED D-1733-2015 TERMINATED D-1758-2015 TERMINATED D-1670-2015 TERMINATED D-1611-2015 TERMINATED D-1576-2015 TERMINATED D-1614-2015 TERMINATED D-1755-2015 TERMINATED D-1461-2015 TERMINATED D-1688-2015 TERMINATED D-1470-2015 TERMINATED D-1651-2015 TERMINATED D-1737-2015 TERMINATED D-1443-2015 TERMINATED D-1767-2015 TERMINATED D-1731-2015 TERMINATED D-1432-2015 TERMINATED D-1785-2015 TERMINATED D-1719-2015 TERMINATED D-1543-2015 TERMINATED D-1795-2015 TERMINATED D-1491-2015 TERMINATED D-1694-2015 TERMINATED D-1725-2015 TERMINATED D-1584-2015 TERMINATED D-1718-2015 TERMINATED D-1740-2015 TERMINATED D-1473-2015 TERMINATED D-1749-2015 TERMINATED D-1676-2015 TERMINATED D-1599-2015 TERMINATED D-1626-2015 TERMINATED D-1478-2015 TERMINATED D-1570-2015 TERMINATED D-1518-2015 TERMINATED D-1627-2015 TERMINATED D-1695-2015 TERMINATED D-1442-2015 TERMINATED D-1482-2015 TERMINATED D-1684-2015 TERMINATED D-1791-2015 TERMINATED D-1666-2015 TERMINATED D-1665-2015 TERMINATED D-1557-2015 TERMINATED D-1762-2015 TERMINATED D-1546-2015 TERMINATED D-1462-2015 TERMINATED D-1721-2015 TERMINATED D-1465-2015 TERMINATED D-1713-2015 TERMINATED D-1472-2015 TERMINATED D-1550-2015 TERMINATED D-1484-2015 TERMINATED D-1541-2015 TERMINATED D-1687-2015 TERMINATED D-1595-2015 TERMINATED D-1516-2015 TERMINATED D-1722-2015 TERMINATED D-1488-2015 TERMINATED D-1781-2015 TERMINATED D-1562-2015 TERMINATED D-1457-2015 TERMINATED D-1689-2015 TERMINATED D-1690-2015 TERMINATED D-1610-2015 TERMINATED D-1492-2015 TERMINATED D-1463-2015 TERMINATED D-1621-2015 TERMINATED D-1763-2015 TERMINATED D-1800-2015 TERMINATED D-1554-2015 TERMINATED D-1467-2015 TERMINATED D-1761-2015 TERMINATED D-1604-2015 TERMINATED D-1527-2015 TERMINATED D-1459-2015 TERMINATED D-1639-2015 TERMINATED D-1681-2015 TERMINATED D-1716-2015 TERMINATED D-1677-2015 TERMINATED D-1498-2015 TERMINATED D-1646-2015 TERMINATED D-1757-2015 TERMINATED D-1724-2015 TERMINATED D-1441-2015 TERMINATED D-1579-2015 TERMINATED D-1451-2015 TERMINATED D-1609-2015 TERMINATED D-1596-2015 TERMINATED D-1777-2015 TERMINATED D-1734-2015 TERMINATED D-1679-2015 TERMINATED D-1503-2015 TERMINATED D-1553-2015 TERMINATED D-1525-2015 TERMINATED D-1520-2015 TERMINATED D-1483-2015 TERMINATED D-1434-2015 TERMINATED D-1590-2015 TERMINATED D-1656-2015 TERMINATED D-1598-2015 TERMINATED D-1717-2015 TERMINATED D-1618-2015 TERMINATED D-1565-2015 TERMINATED D-1672-2015 TERMINATED D-1577-2015 TERMINATED D-1575-2015 TERMINATED D-1568-2015 TERMINATED D-1582-2015 TERMINATED D-1764-2015 TERMINATED D-1586-2015 TERMINATED D-1588-2015 TERMINATED D-1702-2015 TERMINATED D-1523-2015 TERMINATED D-1480-2015 TERMINATED D-1452-2015 TERMINATED D-1657-2015 TERMINATED D-1510-2015 TERMINATED D-1779-2015 TERMINATED D-1436-2015 TERMINATED D-1490-2015 TERMINATED D-1680-2015 TERMINATED D-1466-2015 TERMINATED D-1640-2015 TERMINATED D-1729-2015 TERMINATED D-1537-2015 TERMINATED D-1806-2015 TERMINATED D-1739-2015 TERMINATED D-1637-2015 TERMINATED D-1512-2015 TERMINATED D-1726-2015 TERMINATED D-1743-2015 TERMINATED D-1673-2015 TERMINATED D-1555-2015 TERMINATED D-1607-2015 TERMINATED D-1727-2015 TERMINATED D-1458-2015 TERMINATED D-1674-2015 TERMINATED D-1591-2015 TERMINATED D-1669-2015 TERMINATED D-1552-2015 TERMINATED D-1649-2015 TERMINATED D-1715-2015 TERMINATED D-1447-2015 TERMINATED D-1780-2015 TERMINATED D-1593-2015 TERMINATED D-1647-2015 TERMINATED D-1506-2015 TERMINATED D-1810-2015 TERMINATED D-1605-2015 TERMINATED D-1524-2015 TERMINATED D-1778-2015 TERMINATED D-1620-2015 TERMINATED D-1578-2015 TERMINATED D-1513-2015 TERMINATED D-1617-2015 TERMINATED D-1438-2015 TERMINATED D-1735-2015 TERMINATED D-1691-2015 TERMINATED D-1622-2015 TERMINATED D-1493-2015 TERMINATED D-1446-2015 TERMINATED D-1559-2015 TERMINATED D-1667-2015 TERMINATED D-1453-2015 TERMINATED D-1709-2015 TERMINATED D-1790-2015 TERMINATED D-1720-2015 TERMINATED D-1435-2015 TERMINATED D-1547-2015 TERMINATED D-1701-2015 TERMINATED D-1534-2015 TERMINATED D-1744-2015 TERMINATED D-1580-2015 TERMINATED D-1526-2015 TERMINATED D-1508-2015 TERMINATED D-1793-2015 TERMINATED D-1449-2015 TERMINATED D-1705-2015 TERMINATED D-1643-2015 TERMINATED D-1539-2015 TERMINATED D-1658-2015 TERMINATED D-1533-2015 TERMINATED D-1760-2015 TERMINATED D-1706-2015 TERMINATED D-1623-2015 TERMINATED D-1732-2015 TERMINATED D-1675-2015 TERMINATED D-1519-2015 TERMINATED D-1535-2015 TERMINATED D-1573-2015 TERMINATED D-1431-2015 TERMINATED D-1801-2015 TERMINATED D-1645-2015 TERMINATED D-1654-2015 TERMINATED D-1487-2015 TERMINATED D-1798-2015 TERMINATED D-1660-2015 TERMINATED D-1796-2015 TERMINATED D-1600-2015 TERMINATED D-1663-2015 TERMINATED D-1574-2015 TERMINATED D-1545-2015 TERMINATED D-1685-2015 TERMINATED D-1560-2015 TERMINATED D-1528-2015 TERMINATED D-1728-2015 TERMINATED D-1501-2015 TERMINATED D-1630-2015 TERMINATED D-1633-2015 TERMINATED D-1631-2015 TERMINATED D-1753-2015 TERMINATED D-1773-2015 TERMINATED D-1556-2015 TERMINATED D-1784-2015 TERMINATED D-1682-2015 TERMINATED D-1485-2015 TERMINATED D-1497-2015 TERMINATED D-1504-2015 TERMINATED D-1693-2015 TERMINATED D-1636-2015 TERMINATED D-1807-2015 TERMINATED D-1704-2015 TERMINATED D-1805-2015 TERMINATED D-1775-2015 TERMINATED D-1671-2015 TERMINATED D-1782-2015 TERMINATED D-1515-2015 TERMINATED D-1642-2015 TERMINATED D-1803-2015 TERMINATED D-1587-2015 TERMINATED D-1698-2015 TERMINATED D-1788-2015 TERMINATED D-1786-2015 TERMINATED D-1450-2015 TERMINATED D-1511-2015 TERMINATED D-1629-2015 TERMINATED D-1530-2015 TERMINATED D-1542-2015 TERMINATED D-1644-2015 TERMINATED D-1615-2015 TERMINATED D-1469-2015 TERMINATED D-1794-2015 TERMINATED D-1746-2015 TERMINATED D-1766-2015 TERMINATED D-1616-2015 TERMINATED D-1521-2015 TERMINATED D-1748-2015 TERMINATED D-1476-2015 TERMINATED D-1612-2015 TERMINATED D-1549-2015 TERMINATED D-1468-2015 TERMINATED D-1696-2015 TERMINATED D-1811-2015 TERMINATED D-1692-2015 TERMINATED D-1707-2015 TERMINATED D-1571-2015 TERMINATED D-1756-2015 TERMINATED D-1486-2015 TERMINATED D-1802-2015 TERMINATED D-1683-2015 TERMINATED D-1564-2015 TERMINATED D-1799-2015 TERMINATED D-1751-2015 TERMINATED D-1536-2015 TERMINATED D-1567-2015 TERMINATED D-1496-2015 TERMINATED D-1771-2015 TERMINATED D-1540-2015 TERMINATED D-1711-2015 TERMINATED D-1474-2015 TERMINATED D-1437-2015 TERMINATED D-1714-2015 TERMINATED D-1624-2015 TERMINATED D-1514-2015 TERMINATED D-1460-2015 TERMINATED D-1589-2015 TERMINATED D-1723-2015 TERMINATED D-1769-2015 TERMINATED D-1608-2015 TERMINATED D-1741-2015 TERMINATED D-1710-2015 TERMINATED D-1538-2015 TERMINATED D-1774-2015 TERMINATED

Recall Number: D-1433-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
250 ML total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Acetyl-L-Carnitine 250 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05042015@40, 8/2/2015; 03202015@17, 6/18/2015; 04132015@58, 7/12/2015; 04212015@5, 7/20/2015

Recall Number: D-1708-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
86 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 50 mg/ml + Fentanyl 2,000 mcg/ml + Bupivacaine 10 mg/ml Clonidine 200 mcg/ml, Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03162015@70, 6/14/2015; 04142015@72, 5/20/2015

Recall Number: D-1703-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
66 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 45 mg/ml + Bupivacaine 8 mg/ml + Baclofen 25 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02272015@35, 5/28/2015; 04222015@23, 7/21/2015

Recall Number: D-1572-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
33 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 5,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03042015@15, 6/2/2015

Recall Number: D-1509-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
161 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 1,100 IU/ml + Methylcobalamin 0.5 mg/ml Injection, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03242015@21, 5/23/2015; 04132015@32, 6/12/2015; 04172015@45, 6/16/2015; 05052015@40, 7/4/2015

Recall Number: D-1494-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 2,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03122015@2, 6/10/2015

Recall Number: D-1454-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
29 mL Total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Clotrimazole 2% Otic Suspension, ml, Sterile, Room Temperature, Shake Well, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05012015@13, 5/31/2015, 05012015@16, 5/31/2015

Recall Number: D-1606-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
23 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 45 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04142015@80; 7/13/2015

Recall Number: D-1738-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015 03162015@7, 6/14/2015

Recall Number: D-1592-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
458 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02252015@2, 5/26/2015; 03022015@14, 5/31/2015; 03242015@63, 6/22/2015; 04072015@62, 7/6/2015; 04222015@15, 7/21/2015

Recall Number: D-1797-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
8 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01272015@28, 7/26/2015

Recall Number: D-1594-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
129 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 30 mg/ml + Bupivacaine 5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02252015@10, 5/26/2015; 03242015@75, 6/22/2015; 04222015@20, 7/21/2015

Recall Number: D-1619-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
90 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Oxytocin 100 units/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015 03102015@4 6/8/2015 03052015@29 6/3/2015 04272015@37 7/26/2015 05042015@17 8/2/2015

Recall Number: D-1686-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
105 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
LIPO-EXTREME Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03122015@79, 6/10/2015

Recall Number: D-1772-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
19 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (25/2.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01202015@49, 7/19/2015; 04082015@12, 10/5/2015; 04282015@6, 10/25/2015

Recall Number: D-1500-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
66 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 7,500 mcg/ml, + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03092015@13, 6/7/2015; 04032015@25, 7/2/2015; 05012015@47, 7/30/2015

Recall Number: D-1522-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
1043 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05072015@2, 7/6/2015; 04082015@25, 6/7/2015; 03042015@54, 6/2/2015; 04142015@16, 6/13/2015; 03312015@37, 5/30/2015; 04062015@75, 6/5/2015; 05112015@15, 7/10/2015; 04272015@21, 6/26/2015; 04272015@62, 6/26/2015

Recall Number: D-1662-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
33 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Zinc 5 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04292015@91, 7/28/2015

Recall Number: D-1569-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
1588 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@86, 5/31/2015; 04012015@71, 6/30/2015; 02202015@43, 5/21/2015,; 2232015@74, 5/24/2015; 02272015@70, 5/28/2015; 03052015@8, 6/3/2015; 03102015@61, 6/8/2015; 03092015@97, 6/7/2015; 03202015@98, 6/18/2015; 03232015@62, 6/21/2015; 03272015@50, 6/25/2015; 03312015@47, 6/29/2015; 04022015@20, 7/1/2015; 04062015@1, 7/5/2015; 04062015@61, 7/5/2015; 04132015@49, 7/12/2015; 04132015@53, 7/12/2015; 04152015@26, 7/14/2015; 04162015@20, 7/15/2015; 04222015@41, 7/21/2015; 04162015@50, 7/15/2015; 05012015@52, 7/30/2015; 04242015@64, 7/1/2015; 04302015@3, 7/29/2015; 04302015@40, 7/29/2015; 04302015@43, 7/29/2015; 04292015@99, 7/28/2015; 05062015@19, 8/4/2015; 05122015@14, 7/11/2015

Recall Number: D-1444-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
1397 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
B-Complex Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02192015@21, 5/20/2015; 03032015@3, 6/1/2015; 02242015@37, 5/25/2015; 03122015@27, 6/10/2015; 03182015@48, 6/16/2015; 03272015@14, 6/25/2015; 04072015@16, 7/6/2015, 04072015@18, 7/6/2015, 04202015@80, 7/19/2015, 04222015@85, 7/21/2015; 05072015@25, 8/5/2015; 04272015@74, 7/26/2015; 04272015@81, 7/26/2015; 04292015@98, 7/28/2015; 05012015@17, 7/30/2015; 05042015@45, 8/2/2015; 02202015@47, 5/21/2015

Recall Number: D-1809-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
68 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04012015@23, 9/28/2015; 04272015@41, 10/24/2015; 05052015@9, 11/1/2015

Recall Number: D-1808-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
4 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix T-106/PGE 2 0.1/0.14 Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04172015@7, 10/14/2015

Recall Number: D-1787-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
6 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (6.9/0.575/39.375) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04132015@17, 10/10/2015

Recall Number: D-1561-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
63 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05042015@50, 6/8/2015

Recall Number: D-1789-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
70 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix AT-6 (60 mg/4 mg/0.3 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02112015@39, 8/10/2015; 02032015@99, 8/2/2015; 04012015@25, 9/28/2015; 04272015@55, 10/24/2015

Recall Number: D-1699-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
1436 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
MEGA-BURN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@28, 5/31/2015; 04152015@17, 7/14/2015; 04152015@44, 7/14/2015; 02272015@62, 5/28/2015; 03032015@25, 6/1/2015; 03122015@89, 6/10/2015; 03162015@58, 6/14/2015; 03182015@28, 6/16/2015; 03302015@26, 6/28/2015; 04062015@65, 7/5/2015; 04142015@45, 7/13/2015; 04172015@46, 7/16/2015; 04242015@27, 7/23/2015; 04292015@31, 7/28/2015; 04292015@81, 7/28/2015; 5082015@63, 8/6/2015; 04302015@9, 7/29/2015; 05112015@30, 8/9/2015; 5072015@14, 8/5/2015

Recall Number: D-1754-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
12 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02022015@1, 8/1/2015

Recall Number: D-1448-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
129 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Bupivacaine 40 mg/ml +Baclofen 130 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02232015@27, 5/24/2015; 3182015@46, 6/16/2015; 04242015@45, 6/23/2015

Recall Number: D-1700-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
134 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
MEGA-BURN* Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@61, 5/31/2015; 03052015@11, 6/3/2015; 04132015@21, 7/12/2015; 03242015@7, 6/22/2015; 04292015@11, 7/28/2015

Recall Number: D-1601-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03162015@6, 6/14/2015

Recall Number: D-1603-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
86 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 40 mg/ml + Fentanyl 2,000 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04142015@73, 7/13/2015; 03162015@65, 6/14/2015

Recall Number: D-1641-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
37 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate 150 mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015 03202015@1, 9/16/2015, 01192015@54, 7/18/2015; 04082015@4, 10/5/2015

Recall Number: D-1507-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
48 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 1,000 IU/ml + Methylcobalamin 1 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03312015@25, 5/30/2015; 03312015@45, 5/30/2015; 03312015@50, 5/30/2015; 04292015@58, 6/28/2015

Recall Number: D-1531-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
60 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 5,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03272015@23, 5/26/2015; 03312015@20, 5/30/2015; 04062015@4, 6/5/2015; 05112015@23, 7/10/2015

Recall Number: D-1752-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
12 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Bi-Blend 15 mg/ml +Estradiol Valerate 5 mg/ml Injection, Multi-Dose Vial,Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015 03252015@48, 9/21/15

Recall Number: D-1581-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
78 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Mitomycin 0.02% Ophthalmic Solution, single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 06132014@45, 6/13/2015; 02032015@82, 2/3/2016; 03242015@26, 3/23/2016; 08142014@46, 8/14/2015; 07172014@54, 7/17/2015; 12032014@77, 12/3/2015; 03102015@23, 3/9/2016; 03042015@44, 3/3/2016

Recall Number: D-1548-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
40 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 20 mg/ml + Bupivacaine 0.25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03162015@86, 6/14/2015; 04142015@57, 7/13/2015

Recall Number: D-1697-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
461 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
MEGA-BURN Injectable ROCK CREEK, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02272015@77, 5/28/2015; 03122015@85, 6/10/2015; 03252015@29, 6/23/2015; 04072015@54, 7/6/2015; 04172015@69, 7/16/2015; 04272015@45, 7/26/2015

Recall Number: D-1742-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
1222 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01082015@1, 7/7/2015; 11212014@6, 5/20/2015; 11212014@8, 5/20/2015; 1242014@51, 5/23/2015, 11262014@72, 5/25/2015, 01152015@29, 7/14/2015; 02112015@12, 8/10/2015; 12192014@6, 6/17/2015; 12012014@57, 5/30/2015; 12022014@33; 5/31/2015; 12042014@50, 6/2/2015; 12152014@10, 6/13/2015; 12082014@38; 6/6/2015; 12182014@18, 6/16/2015; 12092014@62, 6/7/2015; 12292014@37, 6/27/2015; 12292014@72, 6/29/2015; 01222015@44, 7/21/2015; 01052015@3, 7/4/2015; 01092015@9, 7/8/2015; 01202015@42; 7/19/2015; 04212015@11, 10/18/2015; 01272015@40, 7/26/2015; 01292015@25, 7/28/2015; 01282015@30, 7/27/2015; 02102015@34, 8/9/2015; 02092015@29, 8/8/2015; 02132015@26, 8/12/2015; 02232015@10, 8/22/2015; 02242015@13, 8/23/2015; 02162015@28, 8/15/2015; 04102015@38, 10/7/2015; 05042015@34, 10/31/2015; 02272015@29, 8/26/2015, 03032015@16, 8/30/2015, 03112015@34, 9/7/2015; 03182015@26, 9/14/2015; 03272015@29; 9/23/2015; 04012015@5, 9/28/2015, 04062015@16, 10/3/2015; 04032015@57, 9/30/2015; 04212015@42; 10/18/2015; 05012015@6, 10/28/2015; 05072015@57, 11/3/2015; 05042015@13, 10/31/2015; 04272015@39, 10/24/2015, 04282015@60, 10/25/2015; 05062015@14, 11/2/2015; 05112015@28, 11/7/2015

Recall Number: D-1668-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
296 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Calmme Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03232015@1, 6/21/2015; 04222015@8, 7/21/2015; 05052015@7, 8/3/2015

Recall Number: D-1638-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
200 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Sufentanil 50 mcg/ml + Bupivacaine 0.25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04212015@27, 6/2062015; 02272015@42, 5/28/2015; 03112015@3, 6/9/2015; 03162015@85, 6/14/2015; 03242015@3, 6/22/2015; 03302015@63, 6/28/2015, 04062015@44, 7/5/2015; 04142015@63, 7/13/2015; 04212015@28, 6/20/2015; and 05072015@8, 7/6/2015

Recall Number: D-1532-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
28 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 1,200 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03272015@22, 5/26/2015; 04062015@19, 6/5/2015; 04212015@39, 6/20/2015; 04222015@62, 6/21/2015

Recall Number: D-1634-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
4554 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Sodium Ascorbate 500 mg/ml Injection, Preservative Free Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04202015@78, 7/19/2015; 02242015@9, 5/25/2015; 03162015@75, 6/14/2015; 03312015@70, 6/29/2015; 04292015@87, 7/28/2015; 05042015@41, 8/2/2015; 04212015@16, 7/20/2015; 02242015@54, 5/25/2015; and 04222015@65, 7/21/2015

Recall Number: D-1648-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone USP Aqueous 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01122015@25, 7/11/2015; 02232015@48, 8/22/2015; 03242015@27, 9/20/2015

Recall Number: D-1804-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
5 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix T-102 (17.65 mg/0.59 mg/10 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05052015@20, 11/3/2015

Recall Number: D-1583-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
2255 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Mitomycin 40 mg/40 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 10222014@55, 10/22/2015; 10032014@43, 10/3/2015; 12012014@42, 12/1/2015; 01092015@35, 1/9/2016; 02022015@52, 2/2/2016; 02232015@78, 2/23/2016; 03122015@81, 3/11/2016; 03312015@38, 3/30/2016

Recall Number: D-1489-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@2, 5/31/2015

Recall Number: D-1502-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
33 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Folic Acid 5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04222015@69, 7/21/2015

Recall Number: D-1736-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
359 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02252015@3, 5/26/2015; 03022015@17, 5/31/2015; 03162015@60, 6/14/2015; 04012015@1, 6/30/2015; 04142015@66, 7/13/2015; 04272015@28, 6/26/2015

Recall Number: D-1655-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
192 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 75 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05072015@42, 11/3/2015; 12292014@9, 6/27/2015; 12032014@12, 6/1/2015; 12042014@73, 6/2/2015; 02272015@63, 8/26/2015; 05042015@44, 10/31/2015; 03302015@9, 9/26/2015; 04092015@46, 10/6/2015

Recall Number: D-1495-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 5,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03092015@29, 6/7/2015

Recall Number: D-1471-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
144 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12012014@59, 5/30/2015; 01122015@34, 7/11/2015; 02102015@42, 7/1/2015; 03162015@12, 9/12/2015; 04282015@59, 10/25/2015; 05052015@65, 11/1/2015

Recall Number: D-1652-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
24 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 62.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015 05062015@31, 11/2/2015

Recall Number: D-1439-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
76 mL total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01082015@34,7/7/2015; 12162014@46, 6/14/2015; 02032015@98, 8/2/2015; 02112015@79, 8/10/2015, 02192015@15, 8/18/2015

Recall Number: D-1661-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
28 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Vancomycin 25 mg/ml Ophthalmic Solution, Single Dose, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03102015@34 6/8/2015; 03042015@43, 6/2/2015

Recall Number: D-1770-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
26 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (20/2.5/20) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03102015@57 9/6/2015 03092015@71 9/5/2015

Recall Number: D-1765-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
14 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (17.7 mg/1 mg/10 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015 05012015@2, 10/28/2015; 02232015@9, 8/22/2015

Recall Number: D-1653-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
60 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 70 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12182014@19, 6/16/2015; 03192015@38, 9/15/2015; 04072015@9, 10/4/2015

Recall Number: D-1745-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
510 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 200 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12122014@8, 6/10/2015; 12042014@47, 6/2/2015; 01122015@54, 7/11/2015; 04142015@82, 10/11/2015; 01072015@32, 7/6/2015; 01192015@17, 7/18/2015; 02042015@43, 8/3/2015; 02232015@35, 8/22/2015; 02272015@30, 8/26/2015; 02272015@19, 8/26/2015; 03162015@55, 9/12/2015; 03192015@23, 9/15/2015; 03192015@33, 9/15/2015; 04012015@55, 9/28/2015; 04072015@42, 10/4/2015, 04072015@6, 10/4/2015; 04102015@46, 10/7/2015; 04162015@56, 10/13/2015; 04282015@7, 10/25/2015, 04272015@59, 10/24/2015; 04302015@59, 10/27/2015

Recall Number: D-1650-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
49 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone USP (10 AQUEOUS) 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01122015@25, 7/11/2015; 02232015@48, 8/22/2015; 03242015, 9/20/2015

Recall Number: D-1566-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
425 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Mannitol 5% Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04072015@30, 7/6/2015; 05042015@23, 8/2/2015

Recall Number: D-1750-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
60 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 70 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12182014@19, 6/16/2015; 03192015@38, 9/15/2015; 04072015@9, 10/4/2015

Recall Number: D-1499-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
23 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04172015@24, 6/16/2015

Recall Number: D-1481-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
44 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 100 mcg/ml +Clonidine 400 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03092015@27, 5/20/2015

Recall Number: D-1440-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
7 mL total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Alprostadil 50 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02032015@24, 8/2/2015

Recall Number: D-1517-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
12 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 5,000 IU/ml + Methylcobalamin 500 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04032015@53, 6/2/2015

Recall Number: D-1544-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 10 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02202015@5, 5/21/2015

Recall Number: D-1585-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
429 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02252015@1, 5/26/2015; 03062015@38, 6/4/2015; 03162015@77, 6/14/2015; 03242015@44, 6/22/2015; 03242015@51, 6/22/2015; 04072015@58, 7/6/2015; 04132015@6, 6/12/2015; 04142015@60, 6/13/2015; 04222015@12, 6/21/2015; 05122015@16, 7/11/2015

Recall Number: D-1776-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
139 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (30/1/10) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01302015@29, 7/29/2015; 04162015@31, 10/13/2015, 12162014@27, 6/14/2015; 01192015@8, 7/18/2015; 01142015@29, 7/13/2015; 01262015@49, 7/25/2015; 01092015@32, 7/8/2015; 01292015@37, 7/28/2015, 02112015@30, 8/10/2015; 02262015@5, 8/25/2015; 02272015@73, 8/26/2015; 03032015@18, 8/30/2015; 03062015@32, 9/2/2015; 03192015@44, 9/15/2015; 03302015@15, 9/26/2015; 04082015@8, 10/5/2015; 04062015@49, 10/3/2015; 04222015@81, 10/19/2015; 04302015@36, 10/27/2015; 05052015@41, 11/1/2015

Recall Number: D-1455-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
35 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Collagenase 250 units/ml, Sterile, Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05112015@16, 8/9/2015

Recall Number: D-1659-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
94 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 200 mg Anastrazole 9 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01292015@32, 7/28/2015; 02232015@18, 5/20/2015; 02272015@31, 8/26/2015; 03092015@23, 9/5/2015; 03272015@32, 9/23/2015

Recall Number: D-1678-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
66 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 60 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 35 mg/ml + Clonidine 1,200 mcg/ml + Baclofen 90 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03092015@17, 6/7/2015, 04032015@26, 7/2/2015; 5012015@15, 7/30/2015

Recall Number: D-1625-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
533 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Polidocanol 5% Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05062015@45, 8/4/2015, 02272015@13, 5/28/2015, 03102015@46, 6/8/2015, 04172015@17, 7/16/2015

Recall Number: D-1551-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 40 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03202015@79, 6/18/2015

Recall Number: D-1792-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
145 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix ST1 (30 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02112015@15, 8/10/2015 04012015@18 9/28/2015 04272015@52 10/24/2015 05052015@14 11/1/2015

Recall Number: D-1505-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
3120 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 1,000 IU/ml + Methylcobalamin 0.05 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04152015@15, 6/14/2015; 03232015@64, 5/22/2015; 04222015@68, 6/21/2015; 04272015@86, 6/26/2015; 04292015@62, 6/28/2015; 05062015@5, 7/5/2015

Recall Number: D-1768-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
13 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (18/0.6/5.88) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01232015@45, 7/22/2015

Recall Number: D-1558-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
353 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydroxocobalamin 5,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03032015@4, 6/1/2015; 03312015@71, 6/29/2015

Recall Number: D-1602-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
45 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 40 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05042015@3, 8/2/2015; 03122015@101, 5/20/2015

Recall Number: D-1613-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
33 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 64 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04012015@4, 6/30/2015

Recall Number: D-1456-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
35 ML

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Copper (Cupric)Sulfate 2 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05042015@47, 8/2/2015

Recall Number: D-1759-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
7 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate 40 mg/ml Injectable, 5 Sesame, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04152015@56, 10/12/2015

Recall Number: D-1475-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
144 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Estradiol 6 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 11212014@13, 5/20/2015; 12182014@35, 6/16/2015; 02202015@1, 8/19/2015; 03022015@48, 8/29/2015; 03172015@33, 9/13/2015; 04232015@24, 10/20/2015

Recall Number: D-1812-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
7 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix T-50/PGE 2/LIDO 2 0.09/0.32/0.04 Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04282015@33, 10/25/2015

Recall Number: D-1632-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
41 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Sermorelin 1000mcg/GHRP6 1000/GHRP2 1000 ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03242015@91, 5/23/2015; 04012015@50, 5/31/2015; 04242015, 6/23/2015

Recall Number: D-1477-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
32 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Estradiol Cypionate 5mg/ml Injectable, ml Multi-Dose Vial, Sterile Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03122015@48, 9/8/2015; 04212015@20, 10/18/2015; 05052015@37, 11/1/2015

Recall Number: D-1597-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
296 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 35 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04142015@64, 7/13/2015; 02252015@4, 5/26/2015; 03162015@59, 6/14/2015; 03242015@71, 6/22/2015; 04222015@17, 6/21/2015

Recall Number: D-1747-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
24 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 30 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02192015@41, 8/18/2015

Recall Number: D-1730-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 80 mg/ml + Clonidine 1,800 mcg/ml + Baclofen 730 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04242015@52, 7/23/2015

Recall Number: D-1712-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
70 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 50 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03122015@23, 6/10/2015; 04092015@73, 6/8/2015; 05082015@39, 7/7/2015

Recall Number: D-1783-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
7 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (30/2/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03122015@17, 9/8/2015

Recall Number: D-1464-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
212 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Estradiol 10 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12082014@56, 6/6/2015; 01222015@28, 7/21/2015; 01062015@73, 7/5/2015; 03022015@55, 8/29/2015; 03242015@94, 9/20/2015; 04222015@32, 10/19/2015; 04222015@47, 10/19/2015; 04222015@49, 10/19/2015; 04302015@54, 10/27/2015

Recall Number: D-1664-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
112 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Bi-Mix #1 (17.365 mg/0.59 mg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02112015@40, 8/10/2015; 03132015@26, 7/20/2015; 04012015@11, 9/28/2015; 04272015@51, 10/24/2015

Recall Number: D-1635-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
66 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Sodium Tetradecyl Sulfate 5% Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03312015@58, 6/29/2015; and 04012015@68, 6/30/2015

Recall Number: D-1445-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Baclofen 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04272015@23, 7/26/2015

Recall Number: D-1479-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
36 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Estradiol Valerate 40 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04302015@35, 10/27/2015

Recall Number: D-1529-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
45 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 3,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04062015@2, 6/5/2015; 04212015@76, 6/20/2015; 04272015@33, 6/26/2015

Recall Number: D-1628-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
229 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Selenium 200 mcg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04162015@17, 7/15/2015; 03202015@25, 6/18/2015; 03272015@36, 6/25/2015; 04292015@89, 7/28/2015, and 05042015@52, 8/2/2015

Recall Number: D-1563-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
45 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Lidocaine 2% with Epinephrine 1:100,000 (Buffered) Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05122015@20, 5/26/2015

Recall Number: D-1733-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
1830 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
LIPOLEAN Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05082015@29, 8/6/2015; 04022015@43, 7/1/2015; 04242015@32, 7/23/2015; 04282015@37, 7/27/2015; 04292015@97, 7/28/2015; 04302015@61, 7/29/2015

Recall Number: D-1758-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
8 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01292015@59, 7/28/2015

Recall Number: D-1670-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 20 mg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03162015@8, 6/14/2015

Recall Number: D-1611-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
133 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 50 mg/ml +Fentanyl 1,000 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@4, 5/31/2015; 03092015@12, 6/7/2015; 03302015@5, 6/28/2015; 04172015@44, 6/16/2015; 04032015@29, 7/202015; 04242015@57, 6/23/2015

Recall Number: D-1576-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
188 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02272015@17, 5/28/2015; 04082015@47, 7/7/2015

Recall Number: D-1614-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
44 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 70 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015 03222015@80, 5/31/2015; 03202015@77, 6/18/2015

Recall Number: D-1755-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
44 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01222015@34, 7/21/2015; 03172015@80, 9/13/2015; 04092015@65, 10/6/2015

Recall Number: D-1461-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
55 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Dexpanthenol 215 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04202015@83, 7/19/2015

Recall Number: D-1688-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
2804 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
LIPO-VITE Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@27, 5/31/2015; 02242015@4, 5/25/2015; 02272015@4, 5/28/2015; 03052015@1, 6/3/2015; 03132015@49, 6/11/2015; 03162015@29, 6/14/2015; 03182015@1, 6/16/2015; 03172015@13, 6/15/2015; 03172015@17, 6/15/2015; 03172015@20, 6/15/2015; 03182015@18, 6/16/2015; 03232015@14, 6/21/2015; 04272015@57, 7/26/2015; 03302015@31, 6/28/2015; 04092015@24, 7/8/2015; 03312015@46, 6/29/2015; 03312015@55, 6/29/2015; 04022015@61, 7/1/2015; 04032015@17, 7/2/2015; 04072015@11, 7/6/2015; 04072015@11, 7/6/2015; 04102015@51, 7/9/2015; 04142015@69, 7/13/2015; 04142015@83, 7/13/2015; 04212015@6, 7/20/2015; 05052015@95, 8/3/2015; 04222015@50, 7/21/2015; 05042015@26, 8/2/2015; 04292015@5, 7/28/2015; 04272015@50, 7/26/2015; 04302015@37, 7/29/2015; 05012015@39, 7/30/2015; 05112015@24, 8/9/2015

Recall Number: D-1470-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
48 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Estradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02242015@1, 8/23/2015; 05042015@29, 10/31/2015

Recall Number: D-1651-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
216 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 50 mg Pellet, Sterile, The Compounding Pharmacy of America, Inc., Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12032014@47, 6/1/2015; 12052014@36, 6/3/2015; 12192014@33, 6/17/2015; 01202015@53, 7/19/2015; 01062015@58, 7/5/2015; 02122015@40, 8/11/2015; 03022015@15, 8/29/2015; 03252015@22, 9/21/2015; 05082015@6, 11/4/2015

Recall Number: D-1737-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03162015@6, 6/14/2015

Recall Number: D-1443-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
13 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03032015@24, 6/1/2015; 03312015@79, 6/29/2015

Recall Number: D-1767-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
13 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (18 mg/0.6 mg/5.88 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01262015@6, 7/25/2015

Recall Number: D-1731-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
70 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@6, 5/31/2015; 04172015@25, 6/16/2015; 05082015@35, 7/7/2015

Recall Number: D-1432-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
351 ML total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02232015@75, 5/24/2015; 03042015@22, 6/2/2015; 03172015@44, 6/15/2015; 03192015@21, 6/17/2015; 03232015@61, 6/21/2015; 03272015@49, 6/25/2015; 04132015@50, 7/12/2015; 04132015@54, 7/12/201; 04152015@35, 7/14/2015; 04162015@12, 7/15/2015; 04222015@39, 7/21/2015, 04242015@3, 7/23/2015; 05012015@53, 7/30/2015; 05062015@20, 8/4/2015; 05052015@105, 8/3/2015

Recall Number: D-1785-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
25 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (37.5/2/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01162015@4, 7/15/2015; 02272015@47, 8/26/2015

Recall Number: D-1719-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
13 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
TRI-MIX (1/1/40) (MFG) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03042015@7, 8/31/2015

Recall Number: D-1543-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
23 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 10 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04142015@74, 7/13/2015

Recall Number: D-1795-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
9 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix ST3/PGE 2/LIDO 2 0.06/0.2/0.02 Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@76, 8/29/2015

Recall Number: D-1491-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
67 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 17,500 mcg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@3, 5/31/2015; 03202015@54, 6/18/2015; 04172015@34, 6/16/2015

Recall Number: D-1694-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
331 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Lipovicine Modified II Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04152015@29; 7/14/2015; 04212015@31, 7/20/2015

Recall Number: D-1725-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
100 ML

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04022015@36, 7/1/2015

Recall Number: D-1584-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
315 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03102015@55, 3/9/2016; 03172015@62, 3/16/2016; 04102015@7, 4/9/2016

Recall Number: D-1718-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
45 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Quad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02112015@27, 8/10/2015; 02032015@93, 8/2/2015

Recall Number: D-1740-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
25 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
PGE 2 (Alprostadil) 100 mcg/ml, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04282015@46, 10/25/2015; 04302015@31, 10/27/2015; 05072015@36, 11/3/2015

Recall Number: D-1473-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
24 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Estradiol 4 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12182014@21, 6/16/2015

Recall Number: D-1749-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
24 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 60 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04282015@24, 10/25/2015

Recall Number: D-1676-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
45 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 60 mg/ml + Fentanyl 1,000 mcg/ml + Bupivacaine 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03122015@21, 6/10/2015; 04092015@71, 6/8/2015

Recall Number: D-1599-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
103 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02252015@5, 5/26/2015; 03022015@19, 5/31/2015; 04062015@48, 7/5/2015; 04212015@23, 7/20/2015

Recall Number: D-1626-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
18 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Progesterone 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04292015@66, 10/26/2015

Recall Number: D-1478-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
12 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Estradiol Valerate 20 mg/ml Injectable ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 11262014@56, 5/25/2015; 01262015@16, 7/25/2015; 01302015@51, 7/29/2015; 03272015@41, 9/23/2015

Recall Number: D-1570-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
255 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 10,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03052015@5, 6/3/2015; 03162015@63, 6/14/2015; 04222015@70, 7/21/2015

Recall Number: D-1518-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
695 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04092015@6,6/8/2015; 04202015@38, 6/19/2015; 04202015@8, 6/19/2015; 03202015@99, 5/22/2015; 03302015@54, 5/29/2015; 03312015@56, 5/30/2015; 04072015@7, 6/6/2015; 04062015@56, 6/5/2015; 04142015@86, 6/13/2015; 05052015@49, 7/4/2015; 05062015@30, 7/5/2015

Recall Number: D-1627-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
196 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Pyridoxine Hydrochloride 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, Protect from Light, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015 03122015@6/102015; 03202015@29, 6/18/2015, 03232015@3, 6/21/2015

Recall Number: D-1695-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
480 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Lipovicine-Choline 100 mg/ml-Acorbic Acid 45 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03182015@17, 6/16/2015

Recall Number: D-1442-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
2923 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Ascorbic Acid 500 mg/ml Injectable Vial, Sterile Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05052015@1, 8/3/2015; 03112015@4, 6/9/2015; 03122015@32, 6/10/2015; 03122015@90, 6/10/2015; 03232015@6, 6/21/2015; 03272015@38, 6/25/2015; 04072015@21, 7/6/2015; 05112015@75, 8/9/2015; 04222015@9, 7/21/2015

Recall Number: D-1482-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03092015@16, 6/7/2015

Recall Number: D-1684-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
2733 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Lipo-DEN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@26, 5/31/2015; 02272015@22, 5/28/2015; 03092015@75, 6/7/2015; 04092015@97, 7/8/2015; 04092015@37, 7/8/2015; 03022015@78, 5/31/2015; 04102015@6, 7/9/2015; 04242015@31, 7/23/2015

Recall Number: D-1791-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
7 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix MEDIUM (15/0.5/5) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01052015@48, 7/4/2015

Recall Number: D-1666-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
8 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Bi-Mix Medium (30/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12022014@48, 5/31/2015

Recall Number: D-1665-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
12 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Bi-Mix (20/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03092015@34, 9/5/2015

Recall Number: D-1557-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
63 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydroxocobalamin 10,000 mcg/ml Injection, Multi-Dose Vial, sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04212015@52, 7/20/2015

Recall Number: D-1762-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
7 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (15 mg/0.5 mg/5 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01212015@40, 7/20/2015

Recall Number: D-1546-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 15 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03202015@67, 6/18/2015

Recall Number: D-1462-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
262 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Dexpanthenol 250 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03122015@25, 6/10/2015; 03202015@31, 6/18/2015; 03172015@42, 6/15/2015; 03232015@5, 6/21/2015; 04162015@15, 7/15/2015

Recall Number: D-1721-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
160.75 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015

Recall Number: D-1465-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
98 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Estradiol 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01122015@36, 7/11/2015; 04022015@40, 9/29/2015; 05072015@56, 11/3/2015

Recall Number: D-1713-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 60 mg/ml + Fentanyl 12,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,400 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03162015@69, 6/14/2015

Recall Number: D-1472-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
10 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Estradiol 3 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03112015@11, 9/7/2015

Recall Number: D-1550-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
45 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 40 mg/ml + Bupivacaine 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03162015@64, 6/14/2015; 04162015@53, 7/15/2015

Recall Number: D-1484-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03232015@10, 6/21/2015

Recall Number: D-1541-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 1 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04272015@22, 7/26/2015

Recall Number: D-1687-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
305 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
LIPO-Tropic Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02262015@3, 5/27/2015

Recall Number: D-1595-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
87 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 30 mg/ml + Clonidine 250 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03092015@20, 6/7/2015; 03202015@72, 6/18/2015; 04132015@9, 6/12/2015

Recall Number: D-1516-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
5 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 5,000 IU/ml + Methylcobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03242015@47, 5/23/2015

Recall Number: D-1722-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
8 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (15 mg/0.5 mg/20 mcg) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01212015@40, 7/20/2015

Recall Number: D-1488-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
129 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02252015@14, 5/26/2015; 04012015@2, 6/30/2015; 04272015@30, 7/26/2015

Recall Number: D-1781-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
14 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (30/1/22) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01272015@21, 7/26/2015; 03102015@52, 9/6/2015

Recall Number: D-1562-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
160 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Lidocaine 1% Injection, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04062015@78, 7/5/2015

Recall Number: D-1457-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
6615 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015 05062015@2, 8/4/2015; 03182015@9, 6/16/2015; 03242015@9, 6/22/2015; 03312015@72, 6/29/2015; 04152015@12, 7/14/2015; 04152015@13, 7/14/2015; 05052015@93, 8/3/2015; 05012015@35, 7/30/2015; 05072015@10, 8/5/2015

Recall Number: D-1689-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
620 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
LIPO-VITE III, Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02232015@72, 5/24/2015; 02252015@60, 5/26/2015; 03112015@55, 6/9/2015; 03122015@99, 6/10/2015; 03172015@67, 6/15/2015; 03312015@74, 6/29/2015; 05052015@34, 8/3/2015; 04292015@21, 7/28/2015

Recall Number: D-1690-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
775 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Lipotropic (w/Cyanocobalamin 4000 mcg/ml) Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05062015@1, 7/31/2015; 04152015@62, 7/14/2015; 03232015@53, 6/21/2015; 03232015@75, 6/21/2015; 04152015@11, 7/14/2015

Recall Number: D-1610-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
129 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 50 mg/ml + Clonidine 200 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03222015@23, 5/31/2015; 04072015@68, 7/6/2015; 04142015@76, 7/13/2015

Recall Number: D-1492-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03162015@1, 6/14/2015

Recall Number: D-1463-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
30 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04222015@67, 7/21/2015

Recall Number: D-1621-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
209 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
PGE 40 (Alprostadil) 40 mcg/ml Injection, ml, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02112015@31, 8/10/2015; 03132015@28, 9/9/2015; 03272015@5, 9/23/2015; 03262015@17, 9/22/2015; 03272015@17, 9/23/2015; 04012015@28, 9/28/2015

Recall Number: D-1763-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
25 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (17 mg/0.5 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05072015@6, 11/3/2015, 05052015@77, 11/1/2015

Recall Number: D-1800-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
101 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix ST9C (30 mg/2 mg/120 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02112015@22, 8/10/2015; 02032015@87, 8/2/2015; 05062015@3, 11/2/2015; 04272015@53, 10/24/2015

Recall Number: D-1554-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 65 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03162015@5, 6/14/2015

Recall Number: D-1467-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
120 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Estradiol 15 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 11262014@20, 5/25/2015; 01152015@27, 7/14/2015; 02232015@21, 8/22/2015; 02242015@23, 8/23/2015; 05052015@68, 11/1/2015

Recall Number: D-1761-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
8 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (10/0.174/16) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04142015@61, 10/11/2015

Recall Number: D-1604-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
44 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 42 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03122015@4, 6/10/2015; 05012015@22, 7/30/2015

Recall Number: D-1527-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
89 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 30 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04132015@52, 6/12/2015; 04232015@26, 6/22/2015

Recall Number: D-1459-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
38 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Cyanocobalamin 1,000 mcg/ml + B-Complex 100 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04232015@35, 7/22/2015

Recall Number: D-1639-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
394 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
SUPER LIPO Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03312015@51, 6/11/2015; 04142015@18, 7/13/2015; 03302015, 6/28/2015; 04302015@48, 7/29/2015

Recall Number: D-1681-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 70 mg/ml +Fentanyl 16,000 mcg/ml + Bupivacaine 12 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 900 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03122015@24, 6/10/2015

Recall Number: D-1716-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
12 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Quad-Mix 1 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02112015@26, 8/10/2015

Recall Number: D-1677-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
45 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 60 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,000 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03202015@61, 6/18/2015; 04172015@38, 6/16/2015

Recall Number: D-1498-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
23 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 5,000 mcg/ml + Clonidine 3,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04172015@36m, 6/16/2015

Recall Number: D-1646-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
13 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Cholecalciferol 50,000 U/ml, Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04202015@66, 10/17/2015

Recall Number: D-1757-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
45 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate 40 mg/ml (10 ml Sesame Oil), Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04092015@12, 10/6/2015; 03122015@13, 9/8/2015

Recall Number: D-1724-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
761 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Vitatrim Active Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04152015@28, 7/14/2015; 04212015@29, 7/20/2015; 04212015@37, 7/20/2015; 04172015@10, 7/16/2015

Recall Number: D-1441-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
33 mL total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03242015@36, 6/22/2015

Recall Number: D-1579-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
473 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
MIC-B12+B6 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02232015@93, 5/24/2015; 03132015@21, 6/11/2015, 04062015@38, 7/5/2015; 04082015@17, 7/7/2015; 04272015@83, 7/26/2015

Recall Number: D-1451-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
33 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Cholecalciferol 100,000 IU /ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04272015@82, 7/26/2015

Recall Number: D-1609-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
86 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 50 mg/ml + Clonidine 100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02272015@33, 5/28/2015; 04012015@3, 6/30/2015

Recall Number: D-1596-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 33 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03242015@68, 6/22/2015

Recall Number: D-1777-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
27 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (30/1/10) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12022014@50, 5/31/2015; 01092015@31, 7/8/2015; 02102015@43, 8/9/2015; 03272015@42, 9/23/2015

Recall Number: D-1734-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
33 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
LIPOLEAN + Ascorbic Acid 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04132015@56, 7/12/2015

Recall Number: D-1679-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
67 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 60 mg/ml + Fentanyl 7,500 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,100 mcg/ml + Baclofen 600 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@7, 5/31/2015; 03202015@59, 6/18/2015; 04172015@39, 6/16/2015

Recall Number: D-1503-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
559 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Glutathione 200 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03162015@78, 6/14/2015; 03262015@42, 6/24/2015; 04202015@82, 7/19/2015; 04222015@79, 7/21/2015; 05042015@49, 8/2/2015; 04222015@57, 7/21/2015; 04272015@19, 7/26/2015

Recall Number: D-1553-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
44 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 60 mg/ml + Bupivacaine 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02252015@59, 5/26/2015; 03202015@55, 6/18/2015

Recall Number: D-1525-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
60 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 5,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03302015@35, 5/29/2015; 04172015@15, 6/16/2015

Recall Number: D-1520-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
58 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 10,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03252015@5; 5/24/2015; 03232015@34, 5/22/2015; 04152015@40, 6/14/2015; 04072015@46, 6/6/2015; 04222015@16, 6/21/2015; 04302015@46, 6/29/2015

Recall Number: D-1483-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
66 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,300 mcg/ml + Baclofen 350 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04062015@12, 7/5/2015; 04062015@35, 7/5/2015; 05012015@50, 7/30/2015

Recall Number: D-1434-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
33 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Acetyl-L-Carnitine 500 mg/ml, Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04212015@45, 7/20/2015

Recall Number: D-1590-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
66 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 20 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03092015@11, 6/7/2015; 03302015@7, 6/28/2015; 4242015@50, 7/23/2015

Recall Number: D-1656-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
72 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 80 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 11212014@51, 5/20/2015; 02232015@24, 8/22/2015; 05062015@27, 11/2/2015

Recall Number: D-1598-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 36 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile- Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@83, 5/31/2015

Recall Number: D-1717-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
12 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Quad-Mix 2 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05052015@16, 11/1/2015

Recall Number: D-1618-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
200 gm

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Neomycin + Polymyxin B+ Bacitracin Ophthalmic Ointment, grams, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015 01282015@15 and 03182015@54

Recall Number: D-1565-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
376 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Magnesium Sulfate 500 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03122015@31, 6/10/2015; 03202015@23, 6/18/2015; 05042015@79, 8/2/2015, 04272015@75, 7/26/2015; 04292015@61, 7/28/2015

Recall Number: D-1672-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 1,500 mcg/ml + Clonidine 200 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03242015@81, 6/22/2015

Recall Number: D-1577-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
1076 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
MIC+Methylcobalamin 4000 mcg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03172015@50, 6/15/2015; 04142015@11, 7/13/2015; 03232015@32, 6/21/2015; 03232015@37, 6/21/2015; 03302015@53, 6/28/2015; 04142015@10, 7/13/2015; 04302015@47, 7/29/2015; 04292015@84, 7/28/2015; 05042015@55, 8/2/2015

Recall Number: D-1575-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
32 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 1,000 mcg/ml + Hydroxocobalamin 1,000 mcg/ml Injectable, Preservative Free, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04202015@81, 7/19/2015

Recall Number: D-1568-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
63 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04212015@8, 7/20/2015; 03032015@11, 6/1/2015; 03102015@49, 6/8/2015; 03192015@9, 6/17/2015; 05042015@14, 8/2/2015; 04072015@20, 7/6/2015; 05042015@51, 8/2/2015

Recall Number: D-1582-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05112015@22, 5/10/2016; 10202014@63, 10/20/2015; 10272014@17, 10/27/2015; 11102014@20, 11/10/2015; 12302014@8, 12/30/2015; 08252014@26, 8/25/2015; 08262014@20, 8/26/2015; 09052014@13, 9/5/2015; 01262015@15, 1/26/2016; 01022015@22, 1/2/2016; 02232015@50, 2/23/2016; 04132015@59, 4/12/2016; 04222015@40, 4/21/2016; 05062015@21, 5/5/2016; 06042014@17, 6/4/2015

Recall Number: D-1764-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
307 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (17.7 mg/0.59 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01082015@10, 7/7/2015; 12022014@44, 5/31/2015; 12192014@14, 6/17/2015; 01072015@22, 7/6/2015; 01262015@83, 7/25/2015; 02092015@12, 8/8/2015 02132015@5, 8/12/2015; 02202015@19, 8/19/2015; 02192015@24, 8/18/2015; 03022015@49, 8/29/2015; 03302015@1, 9/26/2015; 03312015@12, 9/27/2015; 04012015@63, 9/28/2015; 04162015@37, 10/13/2015; 05042015@37, 10/31/2015

Recall Number: D-1586-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
151 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 12.5 mg/ml Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@13, 5/31/2015; 03162015@51, 6/14/2015; 04072015@59, 7/6/2015; 04272015@26, 7/26/2015

Recall Number: D-1588-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
235 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03122015@98, 6/10/2015; 03162015@57, 6/14/2015; 03162015@79, 6/14/2015; 04062015@42, 7/5/2015; 05042015@4, 7/2/2015; 05042015@69, 7/3/2015; 05122015@17, 7/11/2015

Recall Number: D-1702-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03202015@84, 6/18/2015

Recall Number: D-1523-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
55 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 1,250 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04162015@25, 6/15/2015

Recall Number: D-1480-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
44 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 10,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04062015@14, 7/5/2015; 05012015@48, 7/30/2015

Recall Number: D-1452-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
11 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Cholecalciferol 500,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04102015@10, 7/9/2015; 04162015@41, 7/15/2015; 04092015@21, 7/8/2015

Recall Number: D-1657-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
85 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 60 mg Anastrazole 4 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12032014@36, 6/1/2015; 12082014@22, 6/6/2015; 01202015@19, 7/19/2015; 05042015@81, 10/31/2015; 05112015@19, 11/7/2015; 04282015@44, 10/25/2015

Recall Number: D-1510-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
57 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 15 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04152015@18, 6/14/2015; 04222015@25, 6/21/2015; 04292015@75, 6/28/2015; 05012015@41, 6/30/2015; 05042015@71, 7/3/2015; 05082015@61, 7/7/2015

Recall Number: D-1779-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
8 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (30/1/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05082015@31, 11/4/2015

Recall Number: D-1436-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
130 mL total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12052014@40, 6/3/2015; 12182014@71, 6/16/2015; 01022015@12, 7/1/2015; 02112015@56, 8/10/2015; 02132015@47, 8/12/2015; 03062015@26, 9/2/2015; 03312015@23, 9/27/2015; 04162015@2, 10/13/2015; 05012015@26, 10/28/2015; 05072015@15, 11/3/2015

Recall Number: D-1490-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 1,000 mcg/ml + Bupivacaine 25 mg/ml Baclofen 500 mcg/ml + Clonidine 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03162015@71, 5/20/2015; 04272015@31, 7/26/2015

Recall Number: D-1680-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
44 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 70 mg/ml + Bupivacaine 20 mg/ml + Clonidine 125 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03122015@19, 6/10/2015; 04242015@48, 7/23/2015

Recall Number: D-1466-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
144 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Estradiol 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01082015@8, 7/7/2015; 12052014@62, 6/3/2015; 02242015@10, 8/23/2015; 02122015@29, 7/1/2015; 03032015@19, 8/30/2015; 04232015@13, 10/20/2015

Recall Number: D-1640-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
54 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05062015@65, 10/6/2015; 04162015@52, 10/13/2015; 03132015@16, 9/9/2015

Recall Number: D-1729-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
48 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 70 mg/ml+Fentanyl 16,000 mcg/ml+Bupivacaine 15 mg/ml+Clonidine 1,000 mcg/ml+Baclofen 900 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04092015@82, 6/8/2015; 05082015@37, 7/7/2015

Recall Number: D-1537-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
5 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hyaluronidase 150 units/ml Injection, ml, Sterile, Preservative Free, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02202015@6, 5/21/2015

Recall Number: D-1806-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
222 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix T-105 (30 mg/1 mg/10 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05052015@11, 11/1/2015; 02112015@11, 8/10/2015; 02032015@28, 8/2/2015; 04012015@16, 9/26/2015; 04272015@47, 10/24/2015

Recall Number: D-1739-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
218 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02192015@44, 5/20/2015; 03162015@87, 6/14/2015

Recall Number: D-1637-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
159 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03112015@2, 6/9/2015; 03162015@6/14/2015; 03242015@2, 6/22/2015, 03302015@62, 6/28/2015, 0406201@43, 7/5/2015; 04142015@62, 7/13/2015, 04122015@6/20/2015

Recall Number: D-1512-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
4 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04232015@36, 6/22/2015

Recall Number: D-1726-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
33 ML

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
B-Complex 100 mg/ml Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02202015@47 5/21/2015

Recall Number: D-1743-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
144 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 11262014@67, 5/25/2015; 03022015@70, 8/29/2015; 01052015@50, 7/4/2015; 02052015@72, 8/4/2015; 04302015@53, 10/27/2015

Recall Number: D-1673-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 35 mg/ml + Bupivacaine 4 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03232015@18, 6/21/2015

Recall Number: D-1555-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 70 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03202015@85, 6/18/2015

Recall Number: D-1607-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
944 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 50 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04142015@54, 6/13/2015; 04092015@68, 6/8/2015; 02252015@6, 5/26/2015; 05042015@68, 7/3/2015; 03022015@20, 05/31/2015; 031192015@5, 6/9/2015; 03092015@22, 6/7/2015; 03122015@3, 6/10/2015; 03162015@81, 6/14/2015; 03242015@74, 6/22/2015, 03302015@64, 6/28/2015; 04062015@46, 7/5/2015; 04212015@25, 6/20/2015; 04222015@18, 6/21/2015, 04242015@56, 6/23/2015; 04272015@29, 6/26/2015; 05012015@18, 6/30/2015; 05082015@32, 7/7/2015

Recall Number: D-1727-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
13 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Betamethasone Sodium Phosphate (10 ml) 30 mg/ml Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12122015@76, 6/10/2015

Recall Number: D-1458-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
32 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Cyanocobalamin 10 mg Pellet, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03042015@33, 8/31/2015; 03312015@29, 9/27/2015

Recall Number: D-1674-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
67 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 45 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 15 mg/ml + Baclofen 720 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@8, 5/31/2015, 03202015@60, 6/18/2015; 04172015@29, 6/16/2015

Recall Number: D-1591-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
86 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 25 mg/ml + Baclofen 100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@22, 5/31/2015; 04072015@66, 7/6/2015

Recall Number: D-1669-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
86 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromophone 10 mg/ml + Clonidine 300 mcg/ml + Baclofen 120 mcg/ml Intrathecal Solution, Sterile-reservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015 04142015@68, 7/13/2015; 03162015@67, 5/20/2015

Recall Number: D-1552-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
87 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@10, 5/31/2015; 04132015@4, 6/12/2015; 04222015@1, 6/21/2015

Recall Number: D-1649-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
12 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Propionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04302015@39, 10/27/2015

Recall Number: D-1715-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
13 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
MYO-DEN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03062015@29, 6/4/2015; 02192015@44, 5/20/2015; 03162015@87, 6/14/2015

Recall Number: D-1447-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
44 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02192015@51, 5/20/2015; 04162015@14, 7/15/2015

Recall Number: D-1780-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
14 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (30/1/22) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03112015@1, 9/7/2015; 01272015@24, 7/26/2015

Recall Number: D-1593-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 30 mg/ml + Baclofen 10 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03242015@74, 6/22/2015

Recall Number: D-1647-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
120 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Enanthate 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12022014@35, 5/31/2015; 01122015@40, 7/11/2015; 12312014@28, 6/29/2015; 03022015@71, 8/29/2015; 03122015@1, 9/8/2015; 04222015@2, 10/19/2015; 04282015@48, 10/25/2015

Recall Number: D-1506-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
398 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 1,000 IU/ml + Methylcobalamin 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04172015@3, 6/16/2015; 03242015@49, 5/23/2015; 03272015@31, 5/26/2015; 05052015@51, 7/4/2015; 03252015@2, 5/24/2015; 03252015@30, 5/24/2015; 03302015@45, 5/29/2015; 04162015@26, 6/15/2015; 04212015@7, 6/20/2015; 04172015@71, 6/16/2015; 04292015@53, 6/28/2015; 04072015@53, 6/6/2015; 04272015@44, 6/26/2015

Recall Number: D-1810-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
8 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix T-50/PGE 1 0.14/0.08 Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 001072015@39, 7/6/2015

Recall Number: D-1605-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 45 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03232015@6/21/2015

Recall Number: D-1524-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
112 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 11,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04172015@59, 6/16/2015; 04302015@57, 6/29/2015; 03262015@39, 5/25/2015; 04012015@42, 5/31/2015; 04022015@18, 6/1/2015; 04302015@4, 6/29/2015

Recall Number: D-1778-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
16 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (30/1/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05082015@94, 11/4/2015

Recall Number: D-1620-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
188 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
PGE 150 (Alprostadil) 150 mcg/ml, ml, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02112015@33, 04272015@36

Recall Number: D-1578-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
155 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
MIC-B COMPLEX Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02242015@38, 5/25/2015; 05082015@25, 8/6/2015

Recall Number: D-1513-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
39 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03272015@34, 5/26/2015; 05042015@32, 7/3/2015; 04102015@59, 6/9/2015

Recall Number: D-1617-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
24 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Nandrolone Decanoate 250 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03092015@49, 9/5/2015

Recall Number: D-1438-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
11 mL total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Alprostadil 20 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12172014@7, 6/15/2015

Recall Number: D-1735-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
200 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
MEGA-BURN, Winning at Weight Loss Formula Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04292015@11, 7/28/2015

Recall Number: D-1691-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
249 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Lipotropic B-12 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03042015@17, 6/2/2015; 04142015@20, 7/13/2015; 03192015@51, 6/17/2015; 04142015@89, 7/13/2015; 04232015@3, 7/22/2015

Recall Number: D-1622-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
195 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
PGE 80 (Alprostadil) 80 mcg/ml Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02112015@32, 8/10/2015; 04012015@30, 9/28/2015; 04272015@38, 10/24/2015

Recall Number: D-1493-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 2,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03092015@30, 6/7/2015

Recall Number: D-1446-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
66 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Biotin10 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, the Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05042015@46, 8/2/2015

Recall Number: D-1559-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
165 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydroxocobalamin 10 mg/ml Folic Acid 4 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03202015@28, 6/18/2015; 05042015@42, 8/2/2015

Recall Number: D-1667-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
426 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Buckshot Injectable, Multi-Dose, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03232015@2, 6/21/2015; 05052015@8, 8/3/2015; 04222015@7, 7/21/2015

Recall Number: D-1453-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
260 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03102015@17, 6/8/2015; 03032015@14, 6/1/2015; 03272015@1, 6/25/2015; 04292015@79, 7/28/2015, 04282015@51, 7/27/2015

Recall Number: D-1709-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
44 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Baclofen 450 mcg/ml, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03202015@57, 6/18/2015; 04242015@53, 7/23/2015

Recall Number: D-1790-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
802 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix MEDIUM (15 mg/0.5 mg/5 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12182014@66, 6/16/2015; 01052015@51, 7/4/2015; 01192015@33, 7/18/2015; 02192015@9, 8/18/2015; 05042015@38, 10/31/2015; 04012015@63, 9/28/2015

Recall Number: D-1720-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01202015@30, 7/19/2015; 01262015@22, 7/25/2015; 02092015@14, 7/1/2015; 02192015@12, 8/18/2015; 03202015@86, 9/16/2015; 03232015@25, 9/19/2015; 04282015@14, 10/25/2015; 04282015@18, 10/25/2015

Recall Number: D-1435-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
99 mL total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05042015@39, 6/8/2015; 04212015@3, 5/26/2015

Recall Number: D-1547-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
130 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03092015@26, 6/7/2015; 03122015@95, 6/10/2015; 04132015@5, 6/12/2015; 04292015@8, 6/28/2015

Recall Number: D-1701-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
44 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 2,000 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03092015@14, 6/7/2015; 04242015@54, 7/23/2015

Recall Number: D-1534-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
20 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03042015@6, 6/2/2015; 03122015@80, 6/10/2015; 03262015@43, 6/24/2015

Recall Number: D-1744-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
24 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03032015@43, 8/30/2015

Recall Number: D-1580-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
806 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
MIC-PLUS Carnitine Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02252015@29, 5/26/2015; 03112015@36, 6/9/2015; 03192015@18, 6/17/2015; 04162015@40, 7/15/2015

Recall Number: D-1526-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
40 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 1,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04012015@78, 5/31/2015; 04222015@61, 6/21/2015; 04302015@55, 6/29/2015

Recall Number: D-1508-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
12 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 1,000 IU/ml + MIC B-12 Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05052015@55, 8/3/2015

Recall Number: D-1793-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
10 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix ST2 (30 mg/3 mg/100 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04302015@29, 10/27/2015

Recall Number: D-1449-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Bupivacaine 15 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03092015@3, 6/7/2015

Recall Number: D-1705-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
44 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03092015@25, 6/7/2015; 04242015@44, 7/23/2015

Recall Number: D-1643-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
13 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04172015@10/14/2015

Recall Number: D-1539-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
18 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hyaluronidase 175 units/ml Injection, ml, Sterile, Preserved, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03112015@15, 6/9/2015

Recall Number: D-1658-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
10 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 200 mg Anastrazole 1 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03162015@38, 9/12/2015

Recall Number: D-1533-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
200 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04092015@59, 6/8/2015; 04162015@28, 6/15/2015; 03272015@2, 5/26/2015; 03302015@34, 5/29/2015; 04062015@71, 6/5/2015; 04162015@54, 6/15/2015; 05012015@36, 6/30/2015; 05112015@5, 7/10/2015

Recall Number: D-1760-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
15 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Tri-Blend 200 mg/ml (10 ml Sesame Oil) Injection, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01122015@49, 7/11/2015

Recall Number: D-1706-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
129 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 50 mg/ml + Fentanyl 1,500 mcg/ml + Baclofen 800 mcg/ml +Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02252015@12, 5/20/2015; 03242015@80, 6/22/2015; 04222015@24, 7/21/2015

Recall Number: D-1623-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
100 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Phosphatidylcholine 0.1% Sodium Deoxycholate 0.089% Injection, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05112015@18, 8/9/2015

Recall Number: D-1732-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml + Baclofen 750 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04272015@27, 6/26/2015

Recall Number: D-1675-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
23 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04072015@70, 7/6/2015

Recall Number: D-1519-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
1558 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05062015@32, 8/4/2015; 02272015@16, 5/28/2015; 03032015@33, 6/1/2015; 03042015@36, 6/2/2015; 03062015@43, 6/4/2015; 03092015@77, 6/7/2015; 03092015@92, 6/7/2015; 03132015@17, 11/2015; 03162015@23, 14/2015; 03172015@40, 5/2015; 03232015@39, 6/21/2015; 03242015@23, 6/22/2015; 03242015@29, 6/22/2015; 04162015@46, 7/15/2015; 04012015@8, 6/30/2015; 04062015@10, 7/5/2015; 04072015@17, 7/6/2015; 04142015@2, 7/13/2015; 04132015@34, 7/12/2015; 04202015@45, 7/19/2015; 04172015@63, 7/16/2015; 04272015@5, 7/26/2015; 05082015@44, 8/6/2015

Recall Number: D-1535-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
8 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hyaluronic Acid Sodium 32 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03232015@42, 6/21/2015; 03252015@25, 6/23/2015

Recall Number: D-1573-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
99 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 25,000 mcg/ml Intramuscular, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02192015@39, 5/20/2015; 03172015@46, 6/15/2015; 04162015@43, 7/15/2015

Recall Number: D-1431-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
23 ML total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05012015@19, 7/30/2015

Recall Number: D-1801-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
79 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix ST9E (60 mg/4 mg/150 mcg) Injectable, Sterile Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02112015@24, 8/10/2015; 02032015@101, 8/2/2015, 04012015@21, 9/28/2015

Recall Number: D-1645-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
89 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate 200 mg/ml Anastrazole 2 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015

Recall Number: D-1654-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
96 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 72.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01122015@63, 7/11/2015; 03162015@9, 9/12/2015; 03232015@13, 9/19/2015; 05012015@23, 10/28/2015

Recall Number: D-1487-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 8,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03202015@70, 6/18/2015; 03242015@103, 6/22/2015

Recall Number: D-1798-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
112 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix ST9A (30 MG/2 MG/80 MCG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015

Recall Number: D-1660-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
1 pellet

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 75 mg and B12 6 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02242015@49, 8/23/2015

Recall Number: D-1796-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
10 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix ST4 (3 mg/1.5 mg/300 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01272015@29, 7/26/2015

Recall Number: D-1600-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03162015@7, 6/14/2015

Recall Number: D-1663-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
130 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Zinc Chloride 25mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05042015@54, 8/2/2015

Recall Number: D-1574-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
78 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 10 mg/ml + 5 Methyl Tetrahydrofolate 4 mg/ml Injectable, Sterile-Multi-Dose Vial,Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04212015@36, 7/20/2015; 03202015@56, 6/18/2015; 03182015@10, 6/16/2015

Recall Number: D-1545-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
86 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 12.5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03162015@50, 6/14/2015; 04142015@81, 7/13/2015

Recall Number: D-1685-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
1650 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
LIPO-DEN MODIFIED Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@68, 5/31/2015; 04102015@4, 7/9/2015; 04242015@23, 7/23/2015

Recall Number: D-1560-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
37 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydroxyprogesterone Caproate (17-HP) 250 mg/ml Injectable, Multi-Dose Vial, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04162015@27, 10/13/2015; 04032015@20, 9/30/2015; 04202015@47, 10/17/2015

Recall Number: D-1528-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
99 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 2,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03312015@18, 5/30/2015; 03252015@49, 5/24/2015; 04012015@60 5/31/2015; 05112015@59, 7/10/2015; 04062015@39, 6/5/2015; 04072015@25, 6/6/2015; 04072015@74, 6/6/2015; 04142015@44, 6/13/2015; 04172015@72, 6/16/2015; 04172015@77, 6/16/2015; 04232015@8, 6/22/2015; 04222015@60, 6/21/2015; 04242015@11, 6/23/2015; 04292015@33, 6/28/2015

Recall Number: D-1728-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
44 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 5,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@82, 5/31/2015; 03202015@69, 6/18/2015

Recall Number: D-1501-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 8,000 mcg/ml, + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03242015@103, 6/22/2015

Recall Number: D-1630-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Sermorelin/GHRP2 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04092015@9, 6/8/2015; 04152015@59, 6/14/2015; 04042015@26, 6/6/2015; 04132015@36, 6/12/2015

Recall Number: D-1633-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
32 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Sermorelin 300 mcg/ml + GHRP-2 300 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04012015@76, 5/31/2015, 04062015@11, 6/5/2015

Recall Number: D-1631-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
185 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05072015@31, 7/6/2015; 03232015@11, 5/22/2015; 03302015@44, 5/29/2015; 03272015@16, 5/26/2015; 04222015@81, 6/1/2015; 04032015@15, 6/2/2015; 04142015@9, 6/13/2015; 04232015@11, 6/22/2015; 04272015@42, 6/26/2015; 04292015@86, 6/28/2015

Recall Number: D-1753-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
12 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03252015@48, 9/21/2015

Recall Number: D-1773-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
12 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (25/2.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01202015@32, 7/19/2015

Recall Number: D-1556-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
1098 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03202015@27, 6/18/2015; 04152015@1, 7/14/2015; 04222015@66, 7/21/2015; 05052015@5, 8/3/2015

Recall Number: D-1784-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
13 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (37.5 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015 03042015@18, 8/31/2015

Recall Number: D-1682-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03202015@58, 6/18/2015

Recall Number: D-1485-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
44 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 4,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@85, 5/31/2015; 03202015@76, 6/18/2015

Recall Number: D-1497-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
22 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 5,000 mcg/ml, + Bupivacaine 15 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03202015@73, 6/18/2015

Recall Number: D-1504-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
25 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 1,000 IU/ml + Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05062015@48, 7/5/2015; 03232015@78, 5/22/2015

Recall Number: D-1693-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
128 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Lipotropic Methyl B-12 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03102015@62, 6/8/2015; 03172015@52, 6/15/2015; 03272015@8, 6/25/2015

Recall Number: D-1636-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Sufentanil 45 mcg/ml + Bupivacaine 5 mg/ml Solution, Sterile=Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015 04142015@70, 7/13/2015

Recall Number: D-1807-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
300 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix T-106 (30 mg/1 mg/25 mcg) Injectable,The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02032015@57, 8/2/2015; 02112015@14, 8/10/2015; 04012015@17, 9/28/2015; 04272015@49, 10/24/2015; 05052015@12, 11/1/2015

Recall Number: D-1704-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 50 mg/ml + Clonidine 500 mcg/ml +Bupivacaine 2.5 mg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04012015@6, 6/30/2015

Recall Number: D-1805-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
19 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix T-102/PGE 2/LIDO 2 0.06/0.3/0.2 Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05062015@38, 11/2/2015

Recall Number: D-1775-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
8 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (30/0.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12302014@48, 6/28/2015

Recall Number: D-1671-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
67 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 3 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@5, 5/31/2015; 03202015@53, 6/18/2015; 04172015@37, 6/16/2015

Recall Number: D-1782-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
32 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (30/2/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015 03042015@5, 8/31/2015; 03122015@51, 9/8/2015; 04072015@27, 10/4/2015

Recall Number: D-1515-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
10 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 42 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05082015@49, 7/7/2015

Recall Number: D-1642-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
9026 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate 200mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01142015@3, 7/13/2015; 01142015@13, 7/13/2015; 03032015@47, 8/30/2015; 05042015@33, 10/31/2015; 11242014@30, 5/23/2015; 11242014@34, 5/23/2015; 12182014@79, 6/16/2015; 12232014@4, 6/21/2015; 01232015@28, 7/22/2015; 01142015@17, 7/13/2015; 01302015@6, 7/29/2015; 02022015@5, 8/1/2015; 04092015@10, 10/6/2015; 02162015@4, 8/15/2015; 02192015@19, 8/18/2015; 03032015@48, 8/30/2015; 03202015@100, 9/16/2015; 03202015@11, 9/16/2015; 04132015@18, 10/10/2015; 04202015@14, 10/17/2015; 03302015@12, 9/26/2015; 04062015@23, 10/3/2015; 04082015@10, 10/5/2015; 04242015@1, 10/21/2015; 04292015@29, 10/26/2015; 12012014@23, 5/30/2015; 03042015@50, 8/31/2015; 03262015@56, 9/22/2015; 04062015@21, 10/3/2015; 05012015@51, 10/28/2015; 11242014@8, 5/23/2015; 05052015@23, 11/1/2015; 12042014@54, 6/2/2015; 04102015@21, 10/7/2015; 01122015@41, 7/11/2015; 12162014@3, 6/14/2015; 12012014@28, 5/30/2015; 12052014@17, 6/3/2015; 12172014@34, 6/15/2015; 12192014@51, 6/17/2015; 01072015@7, 7/6/2015; 01182015@6, 7/17/2015; 01192015@4, 7/18/2015; 01232015@25, 7/22/2015; 01072015@61, 7/6/2015; 01192015@37, 7/18/2015; 01062015@3, 7/5/2015; 01302015@58, 7/29/2015; 01272015@22, 7/26/2015; 02022015@9, 8/1/2015; 02062015@1, 8/5/2015; 02102015@49, 8/9/2015; 02052015@37, 8/4/2015; 02052015@62, 8/4/2015; 02052015@71, 8/4/2015; 02062015@25, 8/5/2015; 02092015@66, 8/8/2015; 05072015@41, 11/3/2015; 02132015@2, 8/12/2015; 02232015@57, 8/22/2015; 02242015@16, 8/23/2015; 02192015@42, 8/18/2015; 04082015@26, 10/5/2015; 02272015@67, 8/26/2015; 03022015@75, 8/29/2015; 04082015@30, 10/5/2015; 03102015@2, 9/6/2015; 03032015@53, 8/30/2015; 03032015@55, 8/30/2015; 03062015@11, 9/2/2015; 03062015@31, 9/2/2015; 03192015@45, 9/15/2015; 03252015@47, 9/21/2015; 03272015@53, 9/23/2015; 04022015@1, 9/29/2015; 04022015@6, 9/29/2015; 04012015@75, 9/28/2015; 04202015@57, 10/17/2015; 04202015@61, 10/17/2015; 04212015@40, 10/18/2015; 04242015@9, 10/21/2015; 04282015@43, 10/25/2015; and 05052015@21, 11/1/2015

Recall Number: D-1803-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
223 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix T-101 (17.65 mg/0.59 mg/5.9 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02112015@9, 8/10/2015; 02032015@25, 8/2/2015; 04012015@14, 9/28/2015; 05052015@10, 11/1/2015; 04272015@43, 10/24/2015

Recall Number: D-1587-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
86 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 15 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03162015@54, 6/14/2015; 04222015@14, 7/21/2015

Recall Number: D-1698-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
428 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
MEGA-BURN IV Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04142015@6, 7/13/2015; 03132015@9, 6/11/2015; 03122015@100, 6/10/2015; 04142015@15, 7/13/2015; 03302015@46, 6/28/2015; 04302015@49, 7/29/2015

Recall Number: D-1788-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
12 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix AT-1 (8 mg/2 mg/0.2 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04012015@57, 9/28/2015

Recall Number: D-1786-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
38 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (37.5/2/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01152015@60, 7/14/2015; 02272015@34, 8/26/2015; 04012015@27, 9/28/2015

Recall Number: D-1450-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
102 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03202015@26, 6/18/2015; 04282015@1, 7/27/2015; 05042015@53, 8/2/2015

Recall Number: D-1511-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
61 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 2,500 IU/ml + Methylcobalamin 500 mcg/ml, Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03242015@5, 5/23/2015; 05042015@78, 7/3/2015; 03262015@2, 5/25/2015; 04062015@52, 6/5/2015; 04242015@58, 6/23/2015; 05072015@17, 7/6/2015; 05082015@19, 7/7/2015

Recall Number: D-1629-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
77 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Sermorelin 1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04092015@84, 6/8/2015; 04062015@55, 6/5/2015; 04222015@104, 6/21/2015; 04292015@47, 6/28/2015

Recall Number: D-1530-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
53 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 4,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03262015@37, 5/25/2015; 04032015@4, 6/2/2015; 4292015@56, 6/28/2015

Recall Number: D-1542-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
190 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04212015@19, 7/20/2015; 02232015@28, 5/24/2015; 02252015@18, 5/26/2015; 03022015@12, 5/31/2015; 03302015@61, 6/28/2015; 04222015@11, 7/21/2015

Recall Number: D-1644-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
125 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate 200 mg/ml Anastrazole 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04172015@56, 10/14/2015; 04202015@32, 10/17/2015; 049057, 10/21/2015; 05052015@69 11/1/2015; 05082015@43, 11/4/2015

Recall Number: D-1615-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
44 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 70 mg/ml + Clonidine 1,100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02232015@22, 5/24/2015; 03202015@81, 6/18/2015

Recall Number: D-1469-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
120 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Estradiol 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12082014@58, 6/6/2015; 02032015@42, 7/1/2015; 02272015@28, 8/26/2015; 03242015@97, 9/20/2015; 05052015@62, 11/1/2015

Recall Number: D-1794-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
5 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix ST2/LIDO2/PGE2 0.2/0.1/0.04, Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015 04292015@57, 10/26/2015

Recall Number: D-1746-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
240 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12102014@3, 6/8/2015; 12042014@62, 6/2/2015; 01192015@15, 7/18/2015; 01062015@12, 7/5/2015; 02202015@23, 8/19/2015; 02242015@35, 8/23/2015; 03032015@17, 8/30/2015; 03252015@9, 9/21/2015; 04292015@19, 10/26/2015

Recall Number: D-1766-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
62 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (17.7/0.59/6) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01082015@10, 7/7/2015; 12192014@10, 6/17/2015; 12022014@4, 5/31/2015; 12302014@56, 6/28/2015; 01262015@84, 7/25/2015, 03302015@51, 9/26/2015; 05052015@83, 11/1/2015

Recall Number: D-1616-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
169 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Nandrolone Decanoate 200 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015: 02272015@1, 8/26/2015; 12182015@67, 6/16/2015; 02062015@141, 8/5/2015; 04222015@13, 9/29/2015; 04072015@33, 10/4/2015; 04212015@13, 10/18/2015; 04082015@7, 10/5/2015 ; 04142015@24, 10/11/2015; 04272015@84, 10/24/2015; and 05082015@7, 11/4/2015

Recall Number: D-1521-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
51 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 2,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04292015@41, 6/28/2015; 05052015@80, 7/4/2015; 05062015@51, 7/5/2015

Recall Number: D-1748-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
144 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 37.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@79, 8/29/2015; 12092014@5, 6/7/2015; 12042014@28, 6/2/2015; 01152015@30, 7/14/2015; 04152015@24, 10/12/2015

Recall Number: D-1476-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
24 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Estradiol 8 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03182015@14, 9/14/2015

Recall Number: D-1612-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 60 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02232015@19, 5/24/2015

Recall Number: D-1549-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
44 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03122015@93, 6/10/2015; 04242015@46, 7/23/2015

Recall Number: D-1468-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
120 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Estradiol 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12112014@4, 6/9/2015; 02102015@18, 8/9/2015; 03022015@59, 8/29/2015; 03242015@96, 9/20/2015; 04292015@16, 10/26/2015

Recall Number: D-1696-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
3513 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04212015@10, 7/20/2015; 02232015@86, 5/24/2015; 02252015@79, 5/26/2015; 03112015@21, 6/9/2015; 03232015@40, 6/21/2015; 03242015@76, 6/22/2015; 03312015@60, 6/29/2015; 03272015@27, 6/25/2015; 04022015@62, 7/1/2015; 04072015@55, 7/6/2015; 04142015@59, 7/13/2015; 04212015@30, 7/20/2015; 04212015@54, 7/20/2015; 04222015@31, 7/21/2015; 05042015@64, 8/2/2015; 05052015@60, 8/3/2015; 04272015@77, 7/26/2015; 04292015@14, 7/28/2015; 04292015@23, 7/28/2015; 05052015@92, 8/3/2015; 05082015@23, 8/6/2015; 05012015@11, 7/30/2015; 05052015@98, 8/3/2015

Recall Number: D-1811-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
5 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01152015@46, 7/14/2015

Recall Number: D-1692-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
520 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Lipotropic B-12 II* + Lidocaine Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04132015@63, 7/12/2015; 03182015@34, 6/16/2015; 05082015@26, 8/6/2015

Recall Number: D-1707-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 50 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 25 mg/ml, Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03092015@15, 6/7/2015; 04092015@69, 6/8/2015; 05012015@12, 6/30/2015

Recall Number: D-1571-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
79 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 4,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03062015@27, 6/4/2015; 03182015@45, 6/16/2015

Recall Number: D-1756-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
138 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate 220 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 11242014@36, 5/23/2015; 12042014@53, 6/2/2015; 12222014@67, 6/20/2015; 02192015@5, 8/18/2015, 05042015@77, 10/31/2015; 05052015@54, 11/1/2015

Recall Number: D-1486-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
65 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 7,000 mcg/ml + Bupivacaine 6 mg/ml + Clonidine 40 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02252015@51, 5/20/2015; 04222015@22, 7/21/2015

Recall Number: D-1802-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
161 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix SUPER (28 mg/0.9 mg/37 mcg) Injectable, Sterile Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01202015@30, 7/19/2015; 01262015@22, 7/25/2015; 02092015@14, 7/1/2015; 02192015@12, 8/18/2015; 03202015@86, 9/16/2015; 03232015@25, 9/19/2015; 04282015@14, 10/25/2015; 04282015@18, 10/25/2015

Recall Number: D-1683-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
1200 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Lipo-B MMC I (SULFUR FREE) Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04222015@13, 7/21/2015; 05112015@74, 8/9/2015

Recall Number: D-1564-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
924 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Magnesium Chloride 200 mg/ml (20%) Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04202015@79, 7/19/2015; 04072015@24, 7/6/2015; 04222015@10, 7/21/2015; 05052015@4, 8/3/2015

Recall Number: D-1799-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
112 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix ST9A (30 mg/2 mg/80 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02112015@19, 8/10/2015; 02032015@77, 8/2/2015; 04012015@19, 9/28/2015; 04272015@54, 10/24/2015

Recall Number: D-1751-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
265 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 87.5 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@60, 8/29/2015; 12042014@65, 6/2/2015; 12182014@39, 6/16/2015; 01152015@37, 7/14/2015; 01052015@1, 7/4/2015; 02052015@50, 8/4/2015; 02132015@14, 8/12/2015; 03162015@14, 9/12/2015; 03252015@14, 9/21/2015; 04222015@44, 10/19/2015, 05042015@28, 10/31/2015

Recall Number: D-1536-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
33 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hyaluronic Acid Sodium 35 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04062015@66, 7/5/2015; 04072015@57, 7/6/2015

Recall Number: D-1567-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
2442 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 25 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04222015@75, 7/21/2015

Recall Number: D-1496-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Fentanyl 5,000 mcg/ml + Baclofen 250 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04032015@30, 7/2/2015

Recall Number: D-1771-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
8 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (22.5/0.83/8.3) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01272015@51, 7/26/2015

Recall Number: D-1540-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
86 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hydromorphone 0.25 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04092015@64, 7/8/2015; 04032015@28, 7/2/2015

Recall Number: D-1711-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
33 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 50 mg/ml + Ropivacaine 5 mg/ml +Baclofen 20 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04072015@69, 7/6/2015

Recall Number: D-1474-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
96 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Estradiol 50 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 11212014@11, 5/20/2015; 02092015@42, 8/8/2015; 02252015@76, 7/1/2015; 04072015@35, 10/4/2015

Recall Number: D-1437-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
24 mL total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Alprostadil 100 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 12012014@41, 5/30/2015

Recall Number: D-1714-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
185 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Myers Cocktail Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05072015@9, 6/11/2015; 05062015@39, 6/10/2015

Recall Number: D-1624-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
548 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Polidocanol 1% Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04102015@36, 7/9/2015; 03252015@36, 6/23/2015; 04012015@77, 6/30/2015; 04162015@49, 7/15/2015; 04292015@83; 7/28/2015

Recall Number: D-1514-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
56 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 40 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04202015@19, 6/19/2015; 03272015@35, 5/26/2015; 05042015@59, 7/3/2015

Recall Number: D-1460-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
33 mL total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Cyanocobalamin 1,000 mcg/ml + B-Complex 500 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05052015@24, 8/3/2015

Recall Number: D-1589-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 20 mg/ml + Clonidine 400 mcg/ml Solution Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 03022015@81, 5/31/2015

Recall Number: D-1723-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
3215 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Vitatrim Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04102015@70, 7/9/2015; 04212015@9, 7/20/2015; 04092015@75, 7/8/2015; 03022015@1, 5/31/2015; 04202015@12, 7/19/2015; 03112015@19, 6/9/2015; 03032015@36, 6/1/2015; 03032015@40, 6/1/2015; 03062015@28, 6/4/2015; 03192015@5, 6/17/2015; 03202015@15, 6/18/2015; 03172015@18, 6/15/2015; 03172015@27, 7/13/2015; 03202015@87, 6/18/2015; 03242015@35, 6/22/2015; 05042015@76, 8/2/2015; 03272015@9, 6/25/2015; 03312015@14, 6/29/2015; 03272015@33, 6/25/2015; 03272015@43, 6/25/2015; 04012015@37, 6/30/2015; 04022015@32, 7/1/2015; 04162015@39, 7/15/2015; 04232015@5, 7/22/2015; 04212015@65, 7/20/2015; 04222015@48, 7/21/2015; 04272015@65, 7/26/2015; 05052015@96, 8/3/2015; 05012015@34, 7/30/2015; 05052015@87, 8/3/2015; 05072015@53, 8/5/2015

Recall Number: D-1769-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
6 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (20/1/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04292015@78, 10/26/2015

Recall Number: D-1608-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
43 ml total volume

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 50 mg/ml + Bupivacaine 2.5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04142015@77, 6/13/2015

Recall Number: D-1741-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
24 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Testosterone 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 02092015@20, 8/8/2015

Recall Number: D-1710-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
70 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 15 mg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 05082015@38, 7/7/2015; 03122015@15, 6/10/2015; 04092015@72, 6/8/2015

Recall Number: D-1538-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
50 ml total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Hyaluronidase 150 units/ml Injection, ml, Sterile, Preserved, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 04132015@19, 7/12/2015; 02202015@12, 5/21/2015; 05112015@17, 8/9/2015

Recall Number: D-1774-2015

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
06-02-2015
Reported
09-23-2015
Quantity
7 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71371
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Compounding Pharmacy of America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Tri-Mix (30/0.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Batch or Lot Expiration Information

Lot# All lots distributed between November 2014 and May 2015; 01262015@50, 7/25/2015