Multi-event November 2015 FDA Recall Drug by Pine Pharmaceuticals, Llc
This Multi-event Class II drug recall was voluntarily initiated by Pine Pharmaceuticals, Llc on November 4, 2015 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0582-2016
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
11-04-2015
01-27-2016
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pine Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
03-22-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
Batch or Lot Expiration Information
Lot# : 1648@7, exp. 12/20/2015; 1428@4, exp. 11/17/2015
Recall Number: D-0584-2016
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
11-04-2015
01-27-2016
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pine Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
03-22-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
Batch or Lot Expiration Information
Lot# : 1918@5, exp. 1/26/2016; 1820@5, exp. 1/12/2016; 1773@5, exp. 1/6/2016; 1665@5, exp. 12/22/2015; 1542@5, exp. 12/1/2015; 1544@6, exp. 12/1/2015.
Recall Number: D-0581-2016
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
11-04-2015
01-27-2016
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pine Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
03-22-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
Batch or Lot Expiration Information
Lot# : 1956@2, exp. 2/2/2016; 1954@1, exp. 2/2/2016; 1958@3, exp. 2/2/2016; 1943@2, exp. 2/1/2016; 1942@1, exp. 2/1/2016; 1944@3, exp. 2/1/2016; 1938@1, exp. 1/31/2016; 1939@2, exp. 1/31/2016; 1931@1, exp. 1/28/2016; 1932@2, exp. 1/28/2016; 1935@3, exp. 1/28/2016; 1925@1, exp. 1/27/2016; 1927@2, exp. 1/27/2016; 1928@3, exp. 1/27/2016; 1913@3, exp. 1/26/2016; 1917@4, exp. 1/26/2016; 1911@1, exp. 1/26/2016; 1921@6, exp. 1/26/2016; 1906@3, exp. 1/25/2016; 1903@1, exp. 1/25/2016; 1904@2, exp. 1/25/2016; 1899@3, exp. 1/24/2016; 1896@2, exp. 1/24/2016; 1895@1, exp. 1/24/2016; 1886@2, exp. 1/21/2016; 1893@5, exp. 1/21/2016; 1890@4, exp. 1/21/2016; 1885@1, exp. 1/21/2016; 1888@3, exp. 1/21/2016; 1879@5, exp. 1/20/2016; 1872@1, exp. 1/20/2016; 1875@3, exp. 1/20/2016; 1873@2, exp. 1/20/2016; 1867@5, exp. 1/19/2016; 1870@6, exp. 1/19/2016; 1866@4, exp. 1/19/2016; 1854@4, exp. 1/18/2016; 1853@5, exp. 1/18/2016; 1855@6, exp. 1/18/2016; 1839@3, exp. 1/17/2016; 1836@1, exp. 1/17/2016; 1831@2, exp. 1/14/2016; 1813@2, exp. 1/14/2016; 1830@1, exp. 1/14/2016; 1825@1, exp. 1/13/2016; 1818@4, exp. 1/13/2016; 1827@2, exp. 1/13/2016; 1816@3, exp. 1/12/2016; 1812@1, exp. 1/13/2016; 1804@4, exp. 12/31/2015; 1799@6, exp. 1/10/2016; 1797@5, exp. 1/10/2016; 1789@3, exp. 1/7/2016; 1635@5, exp. 12/17/2015; 1490@1, exp. 11/25/2015; 1790@4, exp. 1/7/2016; 1633@4, exp. 12/17/2015; 1492@2, exp. 11/25/2015; 1786@1, exp. 1/7/2016; 1628@2, exp. 12/17/2015; 1497@5, exp. 11/25/2015; 1788@2, exp. 1/7/2016; 1629@3, exp. 12/17/2015; 1486@7, exp. 11/24/2015; 1764@1, exp. 1/6/2016; 1617@1, exp. 12/16/2015; 1476@3, exp. 11/24/2015; 1768@3, exp. 1/6/2016; 1623@4, exp. 12/16/2015; 1474@1, exp. 11/24/2015; 1769@4, exp. 1/6/2016; 1620@3, exp. 12/16/2015; 1466@2, exp. 11/23/2015; 1757@2, exp. 1/5/2016; 1625@5, exp. 12/16/2015; 1473@5, exp. 11/23/2015; 1756@1, exp. 1/5/2016; 1618@2, exp. 12/16/2015; 1465@1, exp. 11/23/2015; 1762@4, exp. 1/5/2016; 1608@2, exp. 12/15/2015; 1460@2, exp. 11/22/2015; 1749@3, exp. 1/4/2016; 1610@3, exp. 12/15/2015; 1458@1, exp. 11/22/2015; 1746@1, exp. 1/4/2016; 1597@2, exp. 12/14/2015; 1450@5, exp. 11/19/2015; 1748@2, exp. 1/4/2016; 1599@4, exp. 12/14/2015; 1447@3, exp. 11/19/2015; 1750@4, exp. 1/4/2016; 1601@5, exp. 12/14/2015; 1448@4, exp. 11/19/2015; 1740@2, exp. 1/3/2016; 1591@1, exp. 12/10/2015; 1436@2, exp. 11/18/2015; 1742@3, exp. 1/3/2016; 1594@3, exp. 12/10/2015; 1441@4, exp. 11/18/2015; 1739@1, exp. 1/3/2016; 1592@2, exp. 12/10/2015; 1443@5, exp. 11/18/2015; 1735@3, exp. 12/31/2015; 1583@3, exp. 12/9/2015; 1439@3, exp. 11/18/2015; 1731@1, exp. 12/31/2015; 1586@4, exp. 12/9/2015; 1435@1, exp. 11/18/2015; 1733@2, exp. 12/31/2015; 1580@1, exp. 12/9/2015; 1423@2, exp. 11/17/2015; 1737@4, exp. 12/31/2015; 1581@2, exp. 12/9/2015; 1433@7, exp. 11/17/2015; 1715@1, exp. 12/30/2015; 1588@5, exp. 12/9/2015; 1422@1, exp. 11/17/2015; 1718@3, exp. 12/30/2015; 1570@1, exp. 12/8/2015; 1417@3, exp. 11/16/2015; 1709@2, exp. 12/29/2015; 1571@2, exp. 12/8/2015; 1416@2, exp. 11/16/2015; 1707@1, exp. 12/29/2015; 1578@5, exp. 12/8/2015; 1420@4, exp. 11/16/2015; 1712@4, exp. 12/29/2015; 1576@4, exp. 12/8/2015; 1413@4, exp. 11/15/2015; 1710@3, exp. 12/29/2015; 1572@3, exp. 12/8/2015; 1412@3, exp. 11/15/2015; 1696@2, exp. 12/28/2015; 1562@1, exp. 12/7/2015; 1396@2, exp. 11/12/2015; 1698@3, exp. 12/28/2015; 1563@2, exp. 12/7/2015; 1402@5, exp. 11/12/2015; 1695@1, exp. 12/28/2015; 1564@3, exp. 12/7/2015; 1398@4, exp. 11/12/2015; 1699@4, exp. 12/28/2015; 1558@1, exp. 12/3/2015; 1392@7, exp. 11/11/2015; 1689@1, exp. 12/27/2015; 1554@4, exp. 12/2/2015; 1388@5, exp. 11/11/2015; 1692@3, exp. 12/27/2015; 1560@2, exp. 12/3/2015; 1385@4, exp. 11/11/2015; 1690@2, exp. 12/27/2015; 1556@5, exp. 12/2/2015; 1372@3, exp. 11/10/2015; 1683@1, exp. 12/24/2015; 1548@1, exp. 12/2/2015; 1371@2, exp. 11/10/2015; 1686@3, exp. 12/24/2015; 1550@3, exp. 12/2/2015; 1369@1, exp. 11/10/2015; 1684@2, exp. 12/24/2015; 1549@2, exp. 12/2/2015; 1360@2, exp. 11/9/2015; 1674@3, exp. 12/23/2015; 1536@3, exp. 12/1/2015; 1365@4, exp. 11/9/2015; 1671@1, exp. 12/23/2015; 1546@7, exp. 12/1/2015; 1359@1, exp. 11/9/2015; 1677@4, exp. 12/23/2015; 1534@1, exp. 12/1/2015; 1363@3, exp. 11/9/2015; 1672@2, exp. 12/23/2015; 1526@1, exp. 11/30/2015; 1352@2, exp. 11/8/2015; 1663@3, exp. 12/22/2015; 1532@4, exp. 11/30/2015; 1351@1, exp. 11/8/2015; 1660@6, exp. 12/22/2015; 1527@2, exp. 11/30/2015; 1345@1, exp. 11/5/2015; 1662@2, exp. 12/22/2015; 1519@2, exp. 11/29/2015; 1346@3, exp. 11/5/2015; 1656@4, exp. 12/21/2015; 1518@1, exp. 11/29/2015; 1349@4, exp. 11/5/2015; 1658@5, exp. 12/21/2015; 1524@4, exp. 11/29/2015; 1338@3, exp. 11/4/2015; 1655@3, exp. 12/21/2015; 1520@3, exp. 11/29/2015; 1343@6, exp. 11/4/2015; 1641@3, exp. 12/20/2015; 1508@4, exp. 11/26/2015; 1340@4, exp. 11/4/2015; 1639@2, exp. 12/20/2015; 1505@2, exp. 11/26/2015; 1334@1, exp. 11/4/2015; 1643@4, exp. 12/20/2015; 1507@3, exp. 11/26/2015; 1335@2, exp. 11/4/2015; 1637@1, exp. 12/20/2015; 1496@4, exp. 11/25/2015; 1627@1, exp. 12/17/2015; 1493@3, exp. 11/25/2015
Recall Number: D-0583-2016
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
11-04-2015
01-27-2016
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pine Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
03-22-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
Batch or Lot Expiration Information
Lot# : 1837@2, exp. 1/17/2016; 1646@6, exp. 12/20/2015
