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 July 25, 2025 and include a total of 16975 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1592-2015 | 06-02-2015 | Morphine 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 / 458 ml total volume | Class II | Terminated |
| D-1797-2015 | 06-02-2015 | Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 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-1594-2015 | 06-02-2015 | Morphine 30 mg/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 / 129 ml total volume | Class II | Terminated |
| D-1772-2015 | 06-02-2015 | Tri-Mix (25/2.5/10) 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 / 19 ml | Class II | Terminated |
| D-1619-2015 | 06-02-2015 | Oxytocin 100 units/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 / 90 ml total volume | Class II | Terminated |
| D-1433-2015 | 06-02-2015 | Acetyl-L-Carnitine 250 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 / 250 ML total volume | Class II | Terminated |
| D-1686-2015 | 06-02-2015 | LIPO-EXTREME 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 / 105 ml | Class II | Terminated |
| D-1569-2015 | 06-02-2015 | Methylcobalamin 1,000 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 / 1588 ml total | Class II | Terminated |
| D-1444-2015 | 06-02-2015 | B-Complex 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 / 1397 mL total volume | Class II | Terminated |
| D-1809-2015 | 06-02-2015 | Tri-Mix T-50 8.8 mg/0.29 mg/2.9 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 / 68 ml | Class II | Terminated |
| D-1808-2015 | 06-02-2015 | Tri-Mix T-106/PGE 2 0.1/0.14 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 / 4 ml | Class II | Terminated |
| D-1787-2015 | 06-02-2015 | Tri-Mix (6.9/0.575/39.375) 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 / 6 ml | Class II | Terminated |
| D-1561-2015 | 06-02-2015 | L-Arginine 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 / 63 ml total | Class II | Terminated |
| D-1789-2015 | 06-02-2015 | Tri-Mix AT-6 (60 mg/4 mg/0.3 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 / 70 ml | Class II | Terminated |
| D-1522-2015 | 06-02-2015 | HCG 625 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 / 1043 ml total | Class II | Terminated |
| D-1662-2015 | 06-02-2015 | Zinc 5 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 / 33 ml | Class II | Terminated |
| D-1500-2015 | 06-02-2015 | Fentanyl 7,500 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 / 66 ml total volume | Class II | Terminated |
| D-1757-2015 | 06-02-2015 | Testosterone Cypionate 40 mg/ml (10 ml Sesame Oil), 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 / 45 ml | Class II | Terminated |
| D-1498-2015 | 06-02-2015 | Fentanyl 5,000 mcg/ml + Clonidine 3,000 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 / 23 ml total volume | Class II | Terminated |
| D-1763-2015 | 06-02-2015 | Tri-Mix (17 mg/0.5 mg/6 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 / 25 ml total | Class II | Terminated |
| D-1646-2015 | 06-02-2015 | 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 | 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-1681-2015 | 06-02-2015 | 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 | 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-1716-2015 | 06-02-2015 | Quad-Mix 1 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 / 12 ml | Class II | Terminated |
| D-1677-2015 | 06-02-2015 | 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 | 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-1459-2015 | 06-02-2015 | Cyanocobalamin 1,000 mcg/ml + B-Complex 100 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 / 38 mL total volume | Class II | Terminated |
| D-1639-2015 | 06-02-2015 | SUPER LIPO 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 / 394 ml | Class II | Terminated |
| D-1527-2015 | 06-02-2015 | HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 30 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 / 89 ml total | Class II | Terminated |
| D-1761-2015 | 06-02-2015 | Tri-Mix (10/0.174/16) 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-1604-2015 | 06-02-2015 | Morphine 42 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 / 44 ml total volume | Class II | Terminated |
| D-1554-2015 | 06-02-2015 | Hydromorphone 65 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-1467-2015 | 06-02-2015 | Estradiol 15 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-1800-2015 | 06-02-2015 | Tri-Mix ST9C (30 mg/2 mg/120 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 / 101 ml | Class II | Terminated |
| D-1621-2015 | 06-02-2015 | PGE 40 (Alprostadil) 40 mcg/ml Injection, 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 / 209 ml total volume | Class II | Terminated |
| D-1463-2015 | 06-02-2015 | DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 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 / 30 mL total volume | Class II | Terminated |
| D-1635-2015 | 06-02-2015 | Sodium Tetradecyl Sulfate 5% 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 / 66 ml | Class II | Terminated |
| D-1445-2015 | 06-02-2015 | Baclofen 1,000 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-1664-2015 | 06-02-2015 | Bi-Mix #1 (17.365 mg/0.59 mg) 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 / 112 ml | Class II | Terminated |
| D-1479-2015 | 06-02-2015 | Estradiol Valerate 40 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 / 36 ml total volume | Class II | Terminated |
| D-1733-2015 | 06-02-2015 | LIPOLEAN 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 / 1830 ml | Class II | Terminated |
| D-1529-2015 | 06-02-2015 | HCG 3,000 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 / 45 ml total | Class II | Terminated |
| D-1563-2015 | 06-02-2015 | Lidocaine 2% with Epinephrine 1:100,000 (Buffered) 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 / 45 ml total | Class II | Terminated |
| D-1628-2015 | 06-02-2015 | Selenium 200 mcg/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 / 229 ml | Class II | Terminated |
| D-1576-2015 | 06-02-2015 | 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 | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 188 ml total | Class II | Terminated |
| D-1611-2015 | 06-02-2015 | Morphine 50 mg/ml +Fentanyl 1,000 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 / 133 ml total volume | Class II | Terminated |
| D-1670-2015 | 06-02-2015 | Hydromorphone 20 mg/ml + Clonidine 1,000 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 | Class II | Terminated |
| D-1758-2015 | 06-02-2015 | Testosterone Cypionate 250 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 / 8 ml | Class II | Terminated |
| D-1614-2015 | 06-02-2015 | Morphine 70 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 / 44 ml total volume | Class II | Terminated |
| D-1755-2015 | 06-02-2015 | Testosterone Cypionate 250 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 / 44 ml | Class II | Terminated |
| D-1688-2015 | 06-02-2015 | LIPO-VITE 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 / 2804 ml | Class II | Terminated |
| 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-1443-2015 | 06-02-2015 | Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, 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 / 13 mL total volume | Class II | Terminated |
| D-1461-2015 | 06-02-2015 | Dexpanthenol 215 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 / 55 mL total volume | Class II | Terminated |
| D-1737-2015 | 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 | Class II | Terminated |
| D-1470-2015 | 06-02-2015 | Estradiol 22 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 / 48 pellets | Class II | Terminated |
| D-1651-2015 | 06-02-2015 | Testosterone 50 mg Pellet, Sterile, 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 / 216 pellets | 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-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-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-1491-2015 | 06-02-2015 | Fentanyl 17,500 mcg/ml + Clonidine 1,000 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 total volume | 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-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-1795-2015 | 06-02-2015 | Tri-Mix ST3/PGE 2/LIDO 2 0.06/0.2/0.02 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 / 9 ml | Class II | Terminated |
| D-1543-2015 | 06-02-2015 | Hydromorphone 10 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 / 23 ml total | Class II | Terminated |
| D-1719-2015 | 06-02-2015 | TRI-MIX (1/1/40) (MFG) 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 / 13 ml | Class II | Terminated |
| D-1785-2015 | 06-02-2015 | Tri-Mix (37.5/2/20) 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 / 25 ml | Class II | Terminated |
| D-1610-2015 | 06-02-2015 | Morphine 50 mg/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 total volume | Class II | Terminated |
| D-1492-2015 | 06-02-2015 | Fentanyl 2,000 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 / 43 ml total volume | Class II | Terminated |
| D-1465-2015 | 06-02-2015 | Estradiol 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 / 98 pellets | Class II | Terminated |
| D-1713-2015 | 06-02-2015 | 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 | 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-1721-2015 | 06-02-2015 | Tri-Mix 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 / 160.75 ml | Class II | Terminated |
| D-1762-2015 | 06-02-2015 | Tri-Mix (15 mg/0.5 mg/5 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 / 7 ml | Class II | Terminated |
| D-1666-2015 | 06-02-2015 | Bi-Mix Medium (30/1) 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-1546-2015 | 06-02-2015 | Hydromorphone 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 / 22 ml total | Class II | Terminated |
| D-1462-2015 | 06-02-2015 | Dexpanthenol 250 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 / 262 mL total volume | Class II | Terminated |
| D-1482-2015 | 06-02-2015 | 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 | 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-1684-2015 | 06-02-2015 | Lipo-DEN 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 / 2733 ml | Class II | Terminated |
| D-1442-2015 | 06-02-2015 | Ascorbic Acid 500 mg/ml Injectable Vial, 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 / 2923 mL total volume | Class II | Terminated |
| D-1791-2015 | 06-02-2015 | Tri-Mix MEDIUM (15/0.5/5) (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 / 7 ml | Class II | Terminated |
| D-1665-2015 | 06-02-2015 | Bi-Mix (20/1) 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-1557-2015 | 06-02-2015 | Hydroxocobalamin 10,000 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 / 63 ml total | Class II | Terminated |
| D-1687-2015 | 06-02-2015 | LIPO-Tropic 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 / 305 ml | Class II | Terminated |
| D-1541-2015 | 06-02-2015 | Hydromorphone 1 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 | Class II | Terminated |
| D-1595-2015 | 06-02-2015 | Morphine 30 mg/ml + Clonidine 250 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 / 87 ml total volume | Class II | Terminated |
| D-1550-2015 | 06-02-2015 | Hydromorphone 40 mg/ml + Bupivacaine 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 / 45 ml total | Class II | Terminated |
| D-1484-2015 | 06-02-2015 | 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 / 22 ml total volume | Class II | Terminated |
| D-1472-2015 | 06-02-2015 | Estradiol 3 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 / 10 pellets | Class II | Terminated |
| D-1722-2015 | 06-02-2015 | Tri-Mix (15 mg/0.5 mg/20 mcg) 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 / 8 ml | Class II | Terminated |
| D-1516-2015 | 06-02-2015 | HCG 5,000 IU/ml + Methylcobalamin 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 / 5 ml total | Class II | Terminated |
| D-1488-2015 | 06-02-2015 | Fentanyl 950 mcg/ml + Bupivacaine 5 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 / 129 ml total volume | Class II | Terminated |
| D-1781-2015 | 06-02-2015 | Tri-Mix (30/1/22) (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 / 14 ml | Class II | Terminated |
| D-1562-2015 | 06-02-2015 | Lidocaine 1% 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 / 160 ml | Class II | Terminated |
| D-1690-2015 | 06-02-2015 | Lipotropic (w/Cyanocobalamin 4000 mcg/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 / 775 ml | Class II | Terminated |
| D-1689-2015 | 06-02-2015 | LIPO-VITE 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 / 620 ml | Class II | Terminated |
| D-1457-2015 | 06-02-2015 | Cyanocobalamin 1,000 mcg/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 / 6615 mL total volume | Class II | Terminated |
| D-1473-2015 | 06-02-2015 | Estradiol 4 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-1749-2015 | 06-02-2015 | Testosterone 60 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-1676-2015 | 06-02-2015 | 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 | 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-1599-2015 | 06-02-2015 | Morphine 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 / 103 ml total volume | Class II | Terminated |
