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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1767-2015 | 06-02-2015 | Tri-Mix (18 mg/0.6 mg/5.88 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 / 13 ml | Class II | Terminated |
| D-1731-2015 | 06-02-2015 | Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, 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 / 70 ml | Class II | Terminated |
| D-1432-2015 | 06-02-2015 | 5-Methy Tetrahydrofolate 5 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 / 351 ML total | Class II | Terminated |
| D-1740-2015 | 06-02-2015 | PGE 2 (Alprostadil) 100 mcg/ml, 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 / 25 ml | Class II | Terminated |
| D-1725-2015 | 06-02-2015 | Baclofen 2,500 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 / 100 ML | Class II | Terminated |
| D-1584-2015 | 06-02-2015 | Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, 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 / 315 ml total volume | Class II | Terminated |
| D-1694-2015 | 06-02-2015 | Lipovicine Modified II 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 / 331 ml | Class II | Terminated |
| D-1718-2015 | 06-02-2015 | Quad-Mix 4 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 / 45 ml | Class II | Terminated |
| D-1468-2015 | 06-02-2015 | Estradiol 18 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 / 120 pellets | Class II | Terminated |
| D-1696-2015 | 06-02-2015 | MEGA-BURN 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 / 3513 ml | Class II | Terminated |
| D-1589-2015 | 06-02-2015 | Morphine 20 mg/ml + Clonidine 400 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 / 43 ml total volume | Class II | Terminated |
| D-1460-2015 | 06-02-2015 | Cyanocobalamin 1,000 mcg/ml + B-Complex 500 mg/ml, 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 / 33 mL total volume | Class II | Terminated |
| D-1741-2015 | 06-02-2015 | Testosterone 18 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-1710-2015 | 06-02-2015 | Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 15 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 / 70 ml | Class II | Terminated |
| D-1538-2015 | 06-02-2015 | Hyaluronidase 150 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 / 50 ml total | Class II | Terminated |
| D-1723-2015 | 06-02-2015 | Vitatrim 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 / 3215 ml | Class II | Terminated |
| D-1769-2015 | 06-02-2015 | Tri-Mix (20/1/10) 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 / 6 ml | Class II | Terminated |
| D-1514-2015 | 06-02-2015 | HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 40 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 / 56 ml total | Class II | Terminated |
| D-1714-2015 | 06-02-2015 | Myers Cocktail 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 / 185 ml | Class II | Terminated |
| D-1624-2015 | 06-02-2015 | Polidocanol 1% 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 / 548 ml total volume | Class II | Terminated |
| D-1540-2015 | 06-02-2015 | Hydromorphone 0.25 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 / 86 ml total | Class II | Terminated |
| D-1437-2015 | 06-02-2015 | Alprostadil 100 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 / 24 mL total | Class II | Terminated |
| D-1474-2015 | 06-02-2015 | Estradiol 50 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 / 96 pellets | Class II | Terminated |
| D-1683-2015 | 06-02-2015 | Lipo-B MMC I (SULFUR FREE) 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 / 1200 ml | Class II | Terminated |
| D-1564-2015 | 06-02-2015 | Magnesium Chloride 200 mg/ml (20%) 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 / 924 ml total | Class II | Terminated |
| D-1756-2015 | 06-02-2015 | Testosterone Cypionate 220 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 / 138 ml | Class II | Terminated |
| D-1486-2015 | 06-02-2015 | 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 | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 65 ml total volume | Class II | Terminated |
| D-1802-2015 | 06-02-2015 | Tri-Mix SUPER (28 mg/0.9 mg/37 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 / 161 ml | Class II | Terminated |
| D-1811-2015 | 06-02-2015 | Tri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 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 / 5 ml | Class II | Terminated |
| D-1692-2015 | 06-02-2015 | Lipotropic B-12 II* + Lidocaine 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 / 520 ml | Class II | Terminated |
| D-1707-2015 | 06-02-2015 | Morphine 50 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 25 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 / | Class II | Terminated |
| D-1571-2015 | 06-02-2015 | Methylcobalamin 4,000 mcg/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 / 79 ml total | Class II | Terminated |
| D-1711-2015 | 06-02-2015 | Morphine 50 mg/ml + Ropivacaine 5 mg/ml +Baclofen 20 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 / 33 ml | Class II | Terminated |
| D-1567-2015 | 06-02-2015 | 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 | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 2442 ml total | Class II | Terminated |
| D-1771-2015 | 06-02-2015 | Tri-Mix (22.5/0.83/8.3) 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 / 8 ml | Class II | Terminated |
| D-1496-2015 | 06-02-2015 | Fentanyl 5,000 mcg/ml + Baclofen 250 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 / 43 ml total volume | Class II | Terminated |
| D-1536-2015 | 06-02-2015 | Hyaluronic Acid Sodium 35 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 / 33 ml total | Class II | Terminated |
| D-1799-2015 | 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-1751-2015 | 06-02-2015 | Testosterone 87.5 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 / 265 pellets | Class II | Terminated |
| D-1774-2015 | 06-02-2015 | Tri-Mix (30/0.5/10) 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 / 7 ml | Class II | Terminated |
| D-1706-2015 | 06-02-2015 | 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 | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 129 ml | Class II | Terminated |
| D-1623-2015 | 06-02-2015 | Phosphatidylcholine 0.1% Sodium Deoxycholate 0.089% Injection, 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 / 100 ml total volume | Class II | Terminated |
| D-1519-2015 | 06-02-2015 | HCG 1,100 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 / 1558 ml total | Class II | Terminated |
| D-1732-2015 | 06-02-2015 | 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 | 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-1675-2015 | 06-02-2015 | 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 | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 23 ml | Class II | Terminated |
| D-1608-2015 | 06-02-2015 | Morphine 50 mg/ml + Bupivacaine 2.5 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 / 43 ml total volume | Class II | Terminated |
| D-1612-2015 | 06-02-2015 | Morphine 60 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-1549-2015 | 06-02-2015 | Hydromorphone 30 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 / 44 ml total | Class II | Terminated |
| D-1766-2015 | 06-02-2015 | Tri-Mix (17.7/0.59/6) (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 / 62 ml | Class II | Terminated |
| D-1616-2015 | 06-02-2015 | Nandrolone Decanoate 200 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 / 169 ml total volume | Class II | Terminated |
| D-1521-2015 | 06-02-2015 | HCG 2,000 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 / 51 ml total | Class II | Terminated |
| D-1748-2015 | 06-02-2015 | Testosterone 37.5 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-1476-2015 | 06-02-2015 | Estradiol 8 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 / 24 pellets | Class II | Terminated |
| D-1469-2015 | 06-02-2015 | Estradiol 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 / 120 pellets | Class II | Terminated |
| D-1794-2015 | 06-02-2015 | Tri-Mix ST2/LIDO2/PGE2 0.2/0.1/0.04, 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 / 5 ml | Class II | Terminated |
| D-1746-2015 | 06-02-2015 | Testosterone 25 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 / 240 pellets | Class II | Terminated |
| D-1615-2015 | 06-02-2015 | Morphine 70 mg/ml + Clonidine 1,100 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 / 44 ml total volume | Class II | Terminated |
| D-1629-2015 | 06-02-2015 | Sermorelin 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 / 77 ml | Class II | Terminated |
| D-1530-2015 | 06-02-2015 | HCG 4,000 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 / 53 ml total | Class II | Terminated |
| D-1542-2015 | 06-02-2015 | Hydromorphone 10 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 / 190 ml | Class II | Terminated |
| D-1644-2015 | 06-02-2015 | Testosterone Cypionate 200 mg/ml Anastrazole 0.5 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 / 125 ml | Class II | Terminated |
| D-1515-2015 | 06-02-2015 | HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 42 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 / 10 ml total | Class II | Terminated |
| D-1642-2015 | 06-02-2015 | Testosterone Cypionate 200mg/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 / 9026 ml | Class II | Terminated |
| D-1803-2015 | 06-02-2015 | Tri-Mix T-101 (17.65 mg/0.59 mg/5.9 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 / 223 ml | Class II | Terminated |
| D-1587-2015 | 06-02-2015 | Morphine 15 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 volume | Class II | Terminated |
| D-1788-2015 | 06-02-2015 | Tri-Mix AT-1 (8 mg/2 mg/0.2 mg) 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-1786-2015 | 06-02-2015 | Tri-Mix (37.5/2/20) (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 / 38 ml | Class II | Terminated |
| D-1450-2015 | 06-02-2015 | Cholecalciferol 50,000 IU/ml Injectable, 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 / 102 mL total volume | Class II | Terminated |
| D-1698-2015 | 06-02-2015 | MEGA-BURN IV 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 / 428 ml | Class II | Terminated |
| D-1511-2015 | 06-02-2015 | HCG 2,500 IU/ml + Methylcobalamin 500 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 / 61 ml total | Class II | Terminated |
| D-1485-2015 | 06-02-2015 | Fentanyl 4,000 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-1497-2015 | 06-02-2015 | Fentanyl 5,000 mcg/ml, + 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 total volume | Class II | Terminated |
| D-1504-2015 | 06-02-2015 | HCG 1,000 IU/ml + Hydroxocobalamin 1,000 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 / 25 ml total volume | Class II | Terminated |
| D-1693-2015 | 06-02-2015 | Lipotropic Methyl 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 / 128 ml | Class II | Terminated |
| D-1782-2015 | 06-02-2015 | Tri-Mix (30/2/20) 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 / 32 ml | Class II | Terminated |
| D-1636-2015 | 06-02-2015 | Sufentanil 45 mcg/ml + Bupivacaine 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 / 43 ml | Class II | Terminated |
| D-1807-2015 | 06-02-2015 | Tri-Mix T-106 (30 mg/1 mg/25 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 / 300 ml | Class II | Terminated |
| D-1704-2015 | 06-02-2015 | Morphine 50 mg/ml + Clonidine 500 mcg/ml +Bupivacaine 2.5 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 / 43 ml | Class II | Terminated |
| D-1805-2015 | 06-02-2015 | Tri-Mix T-102/PGE 2/LIDO 2 0.06/0.3/0.2 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 / 19 ml | Class II | Terminated |
| D-1775-2015 | 06-02-2015 | Tri-Mix (30/0.5/10) (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 / 8 ml | Class II | Terminated |
| D-1671-2015 | 06-02-2015 | Hydromorphone 3 mg/ml + Baclofen 2,500 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 / 67 ml | Class II | Terminated |
| D-1699-2015 | 06-02-2015 | MEGA-BURN III 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 / 1436 ml | Class II | Terminated |
| D-1700-2015 | 06-02-2015 | MEGA-BURN* 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 / 134 ml | Class II | Terminated |
| D-1601-2015 | 06-02-2015 | Morphine 40 mg/ml + Bupivacaine 8 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-1603-2015 | 06-02-2015 | Morphine 40 mg/ml + Fentanyl 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 / 86 ml total volume | Class II | Terminated |
| D-1754-2015 | 06-02-2015 | Testosterone Cypionate 50 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-1448-2015 | 06-02-2015 | Bupivacaine 40 mg/ml +Baclofen 130 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 / 129 mL total volume | Class II | Terminated |
| D-1581-2015 | 06-02-2015 | Mitomycin 0.02% Ophthalmic Solution, single dose dropper, 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 / 78 ml total volume | Class II | Terminated |
| D-1752-2015 | 06-02-2015 | 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 | 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-1641-2015 | 06-02-2015 | Testosterone Cypionate 150 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 / 37 ml | Class II | Terminated |
| D-1507-2015 | 06-02-2015 | HCG 1,000 IU/ml + Methylcobalamin 1 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 / 48 ml total volume | Class II | Terminated |
| D-1531-2015 | 06-02-2015 | HCG 5,000 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 / 60 ml total | Class II | Terminated |
| D-1697-2015 | 06-02-2015 | MEGA-BURN Injectable ROCK CREEK, 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 / 461 ml | Class II | Terminated |
| D-1742-2015 | 06-02-2015 | Testosterone 100 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 / 1222 pellets | Class II | Terminated |
| D-1668-2015 | 06-02-2015 | Calmme 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 / 296 ml | Class II | Terminated |
| D-1548-2015 | 06-02-2015 | Hydromorphone 20 mg/ml + Bupivacaine 0.25 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 / 40 ml total | Class II | Terminated |
| D-1638-2015 | 06-02-2015 | Sufentanil 50 mcg/ml + Bupivacaine 0.25 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 / 200 ml | Class II | Terminated |
| D-1804-2015 | 06-02-2015 | Tri-Mix T-102 (17.65 mg/0.59 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 / 5 ml | Class II | Terminated |
| D-1634-2015 | 06-02-2015 | Sodium Ascorbate 500 mg/ml Injection, Preservative Free 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 / 4554 ml | Class II | Terminated |
| D-1532-2015 | 06-02-2015 | HCG 1,200 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 / 28 ml total | Class II | Terminated |
