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-0506-2016	06-08-2015	METHYLFOLATE Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY	Penicillin Cross Contamination: potentially contaminated with penicillin	Life Science Pharmacy Inc / unknown	Class II	Terminated
D-0495-2016	06-08-2015	ESTRIOL Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY	Penicillin Cross Contamination: potentially contaminated with penicillin	Life Science Pharmacy Inc / unknown	Class II	Terminated
D-0488-2016	06-08-2015	HYDROXOCOBALAMIN Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY	Penicillin Cross Contamination: potentially contaminated with penicillin	Life Science Pharmacy Inc / unknown	Class II	Terminated
D-0501-2016	06-08-2015	TRI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY	Penicillin Cross Contamination: potentially contaminated with penicillin	Life Science Pharmacy Inc / unknown	Class II	Terminated
D-0491-2016	06-08-2015	ESTRIOL Suppositories, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY	Penicillin Cross Contamination: potentially contaminated with penicillin	Life Science Pharmacy Inc / unknown	Class II	Terminated
D-0496-2016	06-08-2015	BI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY	Penicillin Cross Contamination: potentially contaminated with penicillin	Life Science Pharmacy Inc / unknown	Class II	Terminated
D-1238-2015	06-05-2015	Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx Only, Manufactured by Geritrex Corporation, Mount Vernon, NY 10550	CGMP Deviation: Poor container closure of the bulk storage container	Geritrex Corp / 1,488 tubes (1,008 3 oz. tubes and 480 7 oz. tubes)	Class III	Terminated
D-1234-2015	06-04-2015	Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20 Package NDCs: 63323-351-20	Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation	Fresenius Kabi USA, LLC / 7,593 vials	Class II	Terminated
D-1149-2015	06-04-2015	Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor aches and pains of muscles and joints, a) 2 oz. Tube, NDC 10578-035-05, b) 5 oz. Jar, NDC 10578-035-04, Manufactured by Indiana Botanic Gardens, Hobart, IN 46342	Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.	Indiana Botanic Gardens, Inc / a) 630 2 oz. Tubes, b) 859 5 oz. Jars	Class III	Terminated
D-1148-2015	06-04-2015	Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets Each, Rx Only, Manufactured for: Watson Pharm, Inc., a subsidiary of Watson Pharmaceutical, Inc., Corona, CA 92880, Manufactured by: Patheon, Inc., Mississauga, Ontario L9N7K9 Canada, NDC 52544-0949-28	Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.	Actavis Inc / 511,283 Boxes	Class III	Terminated
D-0878-2016	06-03-2015	Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011	Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.	Centro Naturista / Unknown	Class I	Terminated
D-0877-2016	06-03-2015	Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011	Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.	Centro Naturista / Unknown	Class I	Terminated
D-1131-2015	06-03-2015	Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03 Package NDCs: 0338-0431-03; 0338-0433-04; 0338-0424-18; 0338-0428-12	Subpotent Drug; out of specification results for heparin raw material	Baxter Healthcare Corp / 145,350 containers	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-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-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-1609-2015	06-02-2015	Morphine 50 mg/ml + Clonidine 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-1596-2015	06-02-2015	Morphine 33 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-1441-2015	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 / 33 mL total	Class II	Terminated
D-1579-2015	06-02-2015	MIC-B12+B6 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 / 473 ml total	Class II	Terminated
D-1451-2015	06-02-2015	Cholecalciferol 100,000 IU /ml Injectable, ml 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 total volume	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-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-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-1724-2015	06-02-2015	Vitatrim Active 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 / 761 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-1478-2015	06-02-2015	Estradiol Valerate 20 mg/ml Injectable 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 / 12 ml total volume	Class II	Terminated
D-1626-2015	06-02-2015	Progesterone 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 / 18 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
D-1570-2015	06-02-2015	Methylcobalamin 10,000 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 / 255 ml total	Class II	Terminated
D-1518-2015	06-02-2015	HCG 1,000 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 / 695 ml total	Class II	Terminated
D-1627-2015	06-02-2015	Pyridoxine Hydrochloride 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, Protect from Light, The Compounding Pharmacy of America, Knoxville, TN	Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility	The Compounding Pharmacy of America / 196 ml total volume	Class II	Terminated
D-1695-2015	06-02-2015	Lipovicine-Choline 100 mg/ml-Acorbic Acid 45 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 / 480 ml	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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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