Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1447-2015 | 06-02-2015 | Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 44 mL total volume | Class II | Terminated |
| D-1778-2015 | 06-02-2015 | Tri-Mix (30/1/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 16 ml | Class II | Terminated |
| D-1605-2015 | 06-02-2015 | Morphine 45 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 22 ml total volume | Class II | Terminated |
| D-1524-2015 | 06-02-2015 | HCG 11,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 112 ml total | Class II | Terminated |
| D-1513-2015 | 06-02-2015 | HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 39 ml total | Class II | Terminated |
| D-1620-2015 | 06-02-2015 | PGE 150 (Alprostadil) 150 mcg/ml, ml, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 188 ml | Class II | Terminated |
| D-1578-2015 | 06-02-2015 | MIC-B COMPLEX Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 155 ml total | Class II | Terminated |
| D-1555-2015 | 06-02-2015 | Hydromorphone 70 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 22 ml total | Class II | Terminated |
| D-1607-2015 | 06-02-2015 | Morphine 50 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 944 ml total volume | Class II | Terminated |
| D-1673-2015 | 06-02-2015 | Hydromorphone 35 mg/ml + Bupivacaine 4 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 22 ml | Class II | Terminated |
| D-1727-2015 | 06-02-2015 | Betamethasone Sodium Phosphate (10 ml) 30 mg/ml Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 13 ml | Class II | Terminated |
| D-1458-2015 | 06-02-2015 | Cyanocobalamin 10 mg Pellet, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 32 pellets | Class II | Terminated |
| D-1674-2015 | 06-02-2015 | 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 | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 67 ml | Class II | Terminated |
| D-1591-2015 | 06-02-2015 | Morphine 25 mg/ml + Baclofen 100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 86 ml total volume | Class II | Terminated |
| D-1669-2015 | 06-02-2015 | Hydromophone 10 mg/ml + Clonidine 300 mcg/ml + Baclofen 120 mcg/ml Intrathecal Solution, Sterile-reservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 86 ml | Class II | Terminated |
| D-1552-2015 | 06-02-2015 | Hydromorphone 5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 87 ml total | Class II | Terminated |
| D-1649-2015 | 06-02-2015 | Testosterone Propionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 12 ml | Class II | Terminated |
| D-1446-2015 | 06-02-2015 | Biotin10 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, the Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 66 mL total volume | Class II | Terminated |
| D-1667-2015 | 06-02-2015 | Buckshot Injectable, Multi-Dose, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 426 ml | Class II | Terminated |
| D-1709-2015 | 06-02-2015 | Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Baclofen 450 mcg/ml, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 44 ml | Class II | Terminated |
| D-1790-2015 | 06-02-2015 | Tri-Mix MEDIUM (15 mg/0.5 mg/5 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 802 ml | Class II | Terminated |
| D-1720-2015 | 06-02-2015 | Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / | Class II | Terminated |
| D-1547-2015 | 06-02-2015 | Hydromorphone 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 130 ml total | Class II | Terminated |
| D-1701-2015 | 06-02-2015 | Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 2,000 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 44 ml | Class II | Terminated |
| D-1534-2015 | 06-02-2015 | Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 20 ml total | Class II | Terminated |
| D-1622-2015 | 06-02-2015 | PGE 80 (Alprostadil) 80 mcg/ml Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 195 ml total volume | Class II | Terminated |
| D-1691-2015 | 06-02-2015 | Lipotropic B-12 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 249 ml | Class II | Terminated |
| D-1493-2015 | 06-02-2015 | Fentanyl 2,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 22 ml total volume | Class II | Terminated |
| D-1617-2015 | 06-02-2015 | Nandrolone Decanoate 250 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 24 ml total volume | Class II | Terminated |
| D-1438-2015 | 06-02-2015 | Alprostadil 20 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 11 mL total | Class II | Terminated |
| D-1735-2015 | 06-02-2015 | MEGA-BURN, Winning at Weight Loss Formula Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 200 ml | Class II | Terminated |
| D-1559-2015 | 06-02-2015 | Hydroxocobalamin 10 mg/ml Folic Acid 4 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 165 ml total | Class II | Terminated |
| D-1453-2015 | 06-02-2015 | Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 260 mL total volume | Class II | Terminated |
| D-1744-2015 | 06-02-2015 | Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 24 pellets | Class II | Terminated |
| D-1435-2015 | 06-02-2015 | Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 99 mL total | Class II | Terminated |
| D-1654-2015 | 06-02-2015 | Testosterone 72.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 96 pellets | Class II | Terminated |
| D-1801-2015 | 06-02-2015 | Tri-Mix ST9E (60 mg/4 mg/150 mcg) Injectable, Sterile Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 79 ml | Class II | Terminated |
| D-1645-2015 | 06-02-2015 | Testosterone Cypionate 200 mg/ml Anastrazole 2 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 89 ml | Class II | Terminated |
| D-1798-2015 | 06-02-2015 | Tri-Mix ST9A (30 MG/2 MG/80 MCG) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 112 ml | Class II | Terminated |
| D-1660-2015 | 06-02-2015 | Testosterone 75 mg and B12 6 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 1 pellet | Class II | Terminated |
| D-1487-2015 | 06-02-2015 | Fentanyl 8,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 22 ml total volume | Class II | Terminated |
| D-1796-2015 | 06-02-2015 | Tri-Mix ST4 (3 mg/1.5 mg/300 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 10 ml | Class II | Terminated |
| D-1580-2015 | 06-02-2015 | MIC-PLUS Carnitine Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 806 ml total volume | Class II | Terminated |
| D-1526-2015 | 06-02-2015 | HCG 1,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 40 ml total | Class II | Terminated |
| D-1508-2015 | 06-02-2015 | HCG 1,000 IU/ml + MIC B-12 Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 12 ml total volume | Class II | Terminated |
| D-1793-2015 | 06-02-2015 | Tri-Mix ST2 (30 mg/3 mg/100 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 10 ml | Class II | Terminated |
| D-1449-2015 | 06-02-2015 | Bupivacaine 15 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 22 mL | Class II | Terminated |
| D-1705-2015 | 06-02-2015 | Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 44 ml | Class II | Terminated |
| D-1643-2015 | 06-02-2015 | Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 13 ml | Class II | Terminated |
| D-1539-2015 | 06-02-2015 | Hyaluronidase 175 units/ml Injection, ml, Sterile, Preserved, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 18 ml total | Class II | Terminated |
| D-1658-2015 | 06-02-2015 | Testosterone 200 mg Anastrazole 1 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 10 pellets | Class II | Terminated |
| D-1533-2015 | 06-02-2015 | HCG 500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 200 ml total | Class II | Terminated |
| D-1760-2015 | 06-02-2015 | Testosterone Tri-Blend 200 mg/ml (10 ml Sesame Oil) Injection, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 15 ml total | Class II | Terminated |
| D-1535-2015 | 06-02-2015 | Hyaluronic Acid Sodium 32 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 8 ml total | Class II | Terminated |
| D-1573-2015 | 06-02-2015 | Methylcobalamin 25,000 mcg/ml Intramuscular, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 99 ml total | Class II | Terminated |
| D-1431-2015 | 06-02-2015 | 5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 23 ML total | Class II | Terminated |
| D-1773-2015 | 06-02-2015 | Tri-Mix (25/2.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 12 ml | Class II | Terminated |
| D-1631-2015 | 06-02-2015 | Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 185 ml total volume | Class II | Terminated |
| D-1528-2015 | 06-02-2015 | HCG 2,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 99 ml total | Class II | Terminated |
| D-1753-2015 | 06-02-2015 | Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 12 ml | Class II | Terminated |
| D-1501-2015 | 06-02-2015 | Fentanyl 8,000 mcg/ml, + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 22 ml total volume | Class II | Terminated |
| D-1630-2015 | 06-02-2015 | Sermorelin/GHRP2 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 43 ml total volume | Class II | Terminated |
| D-1633-2015 | 06-02-2015 | 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 | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 32 ml | Class II | Terminated |
| D-1728-2015 | 06-02-2015 | Fentanyl 5,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 44 ml total | Class II | Terminated |
| D-1685-2015 | 06-02-2015 | LIPO-DEN MODIFIED Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 1650 ml | Class II | Terminated |
| D-1560-2015 | 06-02-2015 | Hydroxyprogesterone Caproate (17-HP) 250 mg/ml Injectable, Multi-Dose Vial, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 37 ml total | Class II | Terminated |
| D-1600-2015 | 06-02-2015 | Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 43 ml total volume | Class II | Terminated |
| D-1663-2015 | 06-02-2015 | Zinc Chloride 25mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 130 ml | Class II | Terminated |
| D-1574-2015 | 06-02-2015 | Methylcobalamin 10 mg/ml + 5 Methyl Tetrahydrofolate 4 mg/ml Injectable, Sterile-Multi-Dose Vial,Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 78 ml total | Class II | Terminated |
| D-1545-2015 | 06-02-2015 | Hydromorphone 12.5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 86 ml total | Class II | Terminated |
| D-1510-2015 | 06-02-2015 | HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 15 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 57 ml total | Class II | Terminated |
| D-1452-2015 | 06-02-2015 | Cholecalciferol 500,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 11 mL total volume | Class II | Terminated |
| D-1480-2015 | 06-02-2015 | Fentanyl 10,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 44 ml total volume | Class II | Terminated |
| D-1490-2015 | 06-02-2015 | 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 | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 22 ml total volume | Class II | Terminated |
| D-1436-2015 | 06-02-2015 | Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 130 mL total | Class II | Terminated |
| D-1657-2015 | 06-02-2015 | Testosterone 60 mg Anastrazole 4 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 85 pellets | Class II | Terminated |
| D-1779-2015 | 06-02-2015 | Tri-Mix (30/1/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 8 ml | Class II | Terminated |
| D-1729-2015 | 06-02-2015 | 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 | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 48 ml total | Class II | Terminated |
| D-1537-2015 | 06-02-2015 | Hyaluronidase 150 units/ml Injection, ml, Sterile, Preservative Free, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 5 ml total | Class II | Terminated |
| D-1466-2015 | 06-02-2015 | Estradiol 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 144 pellets | Class II | Terminated |
| D-1640-2015 | 06-02-2015 | Testosterone Cypionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 54 ml | Class II | Terminated |
| D-1680-2015 | 06-02-2015 | Hydromorphone 70 mg/ml + Bupivacaine 20 mg/ml + Clonidine 125 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 44 ml | Class II | Terminated |
| D-1806-2015 | 06-02-2015 | Tri-Mix T-105 (30 mg/1 mg/10 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 222 ml | Class II | Terminated |
| D-1739-2015 | 06-02-2015 | MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 218 ml | Class II | Terminated |
| D-1637-2015 | 06-02-2015 | Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 159 ml | Class II | Terminated |
| D-1512-2015 | 06-02-2015 | HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 4 ml | Class II | Terminated |
| D-1726-2015 | 06-02-2015 | B-Complex 100 mg/ml Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 33 ML | Class II | Terminated |
| D-1743-2015 | 06-02-2015 | Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 144 pellets | Class II | Terminated |
| D-1768-2015 | 06-02-2015 | Tri-Mix (18/0.6/5.88) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 13 ml | Class II | Terminated |
| D-1505-2015 | 06-02-2015 | HCG 1,000 IU/ml + Methylcobalamin 0.05 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 3120 ml total volume | Class II | Terminated |
| D-1551-2015 | 06-02-2015 | Hydromorphone 40 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 43 ml total | Class II | Terminated |
| D-1792-2015 | 06-02-2015 | Tri-Mix ST1 (30 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 145 ml | Class II | Terminated |
| D-1759-2015 | 06-02-2015 | Testosterone Cypionate 40 mg/ml Injectable, 5 Sesame, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 7 ml | Class II | Terminated |
| D-1475-2015 | 06-02-2015 | Estradiol 6 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 144 pellets | Class II | Terminated |
| D-1558-2015 | 06-02-2015 | Hydroxocobalamin 5,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 353 ml total | Class II | Terminated |
| D-1602-2015 | 06-02-2015 | Morphine 40 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 45 ml total volume | Class II | Terminated |
| D-1613-2015 | 06-02-2015 | Morphine 64 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 33 ml total volume | Class II | Terminated |
| D-1456-2015 | 06-02-2015 | Copper (Cupric)Sulfate 2 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 35 ML | Class II | Terminated |
| D-1585-2015 | 06-02-2015 | Morphine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 429 ml total volume | Class II | Terminated |
| D-1776-2015 | 06-02-2015 | Tri-Mix (30/1/10) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 139 ml | Class II | Terminated |
