Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0918-2022 | 05-09-2022 | Preserved Ascorbic Acid 500 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0079-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 7420 vials | Class II | Completed |
| D-0944-2022 | 05-09-2022 | PGE-3 Alprostadil 150 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0030-10. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 421 vials | Class II | Completed |
| D-0930-2022 | 05-09-2022 | Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0097-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1195 vials | Class II | Completed |
| D-0900-2022 | 05-09-2022 | SB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0024-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 75 vials | Class II | Completed |
| D-0936-2022 | 05-09-2022 | Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose 10mL vial, NDC 73198-0051-10; b) Multi-Dose 30mL vial, NDC 73198-0051-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 12800 vials | Class II | Completed |
| D-0915-2022 | 05-09-2022 | Vitamin D3 (50,000 IU/mL)Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0075-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 3083 vials | Class II | Completed |
| D-0938-2022 | 05-09-2022 | Myers Cocktail, Magnesium Chloride 9.65 mg/mL Dexpanthenol 4.07 mg/mL Thiamine HCL 1.62 mg/mL Riboflavin-5-Phosphate 3.23 mg/mL Pyridoxine HCL 1.63 mg/mL Niacinamide 1.62 mg/mL Calcium Gluconate 4.07 mg/mL Ascorbic Acid 64.4 mg/mL, Single-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0088-10. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 13679 vials | Class II | Completed |
| D-0948-2022 | 05-09-2022 | QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0019-10. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 414 vials | Class II | Completed |
| D-0914-2022 | 05-09-2022 | Ultratest Testosterone Cypionate 160 mg/mL Testosterone Propionate 40 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0058-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 520 vials | Class II | Completed |
| D-0899-2022 | 05-09-2022 | RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1710 vials | Class II | Completed |
| D-0922-2022 | 05-09-2022 | Cyanocobalamin 2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0115-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1282 vials | Class II | Completed |
| D-0921-2022 | 05-09-2022 | Calcium Chloride 10% (100 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0064-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 5443 vials | Class II | Completed |
| D-0906-2022 | 05-09-2022 | Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0121-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 943 vials | Class II | Completed |
| D-0907-2022 | 05-09-2022 | Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0122-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 480 vials | Class II | Completed |
| D-0941-2022 | 05-09-2022 | Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Manganese Sulfate 20 mcg/mL Copper Gluconate 0.2 mg/mL Sodium Selenite 18 mcg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0061-30. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 6113 vials | Class II | Completed |
| D-0897-2022 | 05-09-2022 | QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0020-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 914 vials | Class II | Completed |
| D-0933-2022 | 05-09-2022 | Lipostat-Plus Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg/mL Pyridoxine HCL 175 mcg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0047-30. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 4843 vials | Class II | Completed |
| D-0908-2022 | 05-09-2022 | Sodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0102-05 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 588 vials | Class II | Completed |
| D-0942-2022 | 05-09-2022 | Olympia Vita-Complex Thiamine HCL (B1) 100 mg/mL Niacinamide (B3) 100 mg/mL Riboflavin 5 P04 (B2) 2 mg/mL Dexpanthenol (B5) 2 mg/mL Pyridoxine HCL (B6) 2 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0063-30. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 8664 vials | Class II | Completed |
| D-0943-2022 | 05-09-2022 | Ondansetron Hydrochloride, 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0127-30. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 911 vials | Class II | Completed |
| D-0898-2022 | 05-09-2022 | RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0015-03; b) 10 mL Multi Dose vial, NDC 73198-0015-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 482 vials | Class II | Completed |
| D-0924-2022 | 05-09-2022 | Dexpanthenol 250 mg/mL Multi-Dose 30 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0070-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1296 vials | Class II | Completed |
| D-0913-2022 | 05-09-2022 | Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL Zinc Sulfate 2.5 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0104-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2260 vials | Class II | Completed |
| D-0929-2022 | 05-09-2022 | Formula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0004-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 205 vials | Class II | Completed |
| D-0905-2022 | 05-09-2022 | Sodium Selenite 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0074-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2333 vials | Class II | Completed |
| D-0946-2022 | 05-09-2022 | Pyridoxine HCL 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0066-30. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1306 vials | Class II | Completed |
| D-0940-2022 | 05-09-2022 | NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0010-10. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 606 vials | Class II | Completed |
| D-0949-2022 | 05-09-2022 | Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine HCL 100 mg/mL Lysine HCL 50 mg/mL Citrulline 50 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835.NDC 73198-0129-30. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 7761 vials | Class II | Completed |
| D-0903-2022 | 05-09-2022 | Diluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0113-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 42,722 vials | Class II | Completed |
| D-0911-2022 | 05-09-2022 | Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0054-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2198 vials | Class II | Completed |
| D-0934-2022 | 05-09-2022 | Lipostat Plus SF Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg/mL Pyridoxine HCL 175 mcg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0048-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1571 vials | Class II | Completed |
| D-0925-2022 | 05-09-2022 | FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, 6700 Olympia Pharmaceuticals, Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0006-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1159 vials | Class II | Completed |
| D-0928-2022 | 05-09-2022 | Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atropine 0.1 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0002-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 72 vials | Class II | Completed |
| D-0909-2022 | 05-09-2022 | T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL, Packaged as a) 2.5 mL Multi-Dose vial NDC 73198-0005-03; b) 5 mL Multi Dose vial, NDC 73198-0005-05, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 3312 vials | Class II | Completed |
| D-0947-2022 | 05-09-2022 | QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine 0.2 mg/mL Multi-Dose 10 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0018-10. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 619 vials | Class II | Completed |
| D-0901-2022 | 05-09-2022 | SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 874 vials | Class II | Completed |
| D-0932-2022 | 05-09-2022 | Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 mg/mL Choline Chloride 25 mg/mL Thiamine HCL (B1) 50 mg/mL Riboflavin5P04 (B2) 5 mg/mL, Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0130-10; b) 30 mL Multi-Dose vial, NDC 73198-0130-30; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 3762 vials | Class II | Completed |
| D-0917-2022 | 05-09-2022 | Alpha Lipoic Acid 25 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0076-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 3286 vials | Class II | Completed |
| D-0902-2022 | 05-09-2022 | Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0059-00 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 4459 vials | Class II | Completed |
| D-0904-2022 | 05-09-2022 | Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0101-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1466 vials | Class II | Completed |
| D-0910-2022 | 05-09-2022 | T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Packaged as a) 5 mL Multi-Dose vial NDC 73198-0013-05; b) 10 mL Multi-Dose vial NDC 73198-0013-10, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 3185 vials | Class II | Completed |
| D-0920-2022 | 05-09-2022 | Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL, Packaged as a) 2.5 mL Multi-Dose Vial, NDC73198-0027-03; b) 10 mL Multi-Dose Vial, NDC 73198-0027-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1287 vials | Class II | Completed |
| D-0945-2022 | 05-09-2022 | Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0021-05. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 9102 vials | Class II | Completed |
| D-0923-2022 | 05-09-2022 | Pyridoxine 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0066-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1306 vials | Class II | Completed |
| D-0919-2022 | 05-09-2022 | AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0040-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 528 vials | Class II | Completed |
| D-0937-2022 | 05-09-2022 | MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalamin 330 mcg/mL, Packaged as a) Multi-Dose 10 mL vial, NDC 73198-0052-10; b) Multi-Dose 30 mL vial, NDC 73198-0052-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 5334 vials | Class II | Completed |
| D-0916-2022 | 05-09-2022 | Zinc Chloride (0.5 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0071-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1291 vials | Class II | Completed |
| D-1145-2022 | 05-06-2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 62756-091-40. Package NDCs: 62756-091-40 | Lack of assurance of sterility | SUN PHARMACEUTICAL INDUSTRIES INC / 4625 syringes | Class II | Terminated |
| D-1146-2022 | 05-06-2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Manufactured for: Northstart Rx LLC, Memphis, TN, 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-981-01. | Lack of assurance of sterility | SUN PHARMACEUTICAL INDUSTRIES INC / 180813 syringes | Class II | Terminated |
| D-1143-2022 | 05-06-2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Afaxys Pharma, LLC, Charleston, SC, 29403, USA, Product of Italy, NDC 50102-591-40. | Lack of assurance of sterility | SUN PHARMACEUTICAL INDUSTRIES INC / 79339 syringes | Class II | Terminated |
| D-1144-2022 | 05-06-2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 16714-999-01. | Lack of assurance of sterility | SUN PHARMACEUTICAL INDUSTRIES INC / 57997 syringes | Class II | Terminated |
| D-1147-2022 | 05-06-2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-090-40 packaged in 25 count carton. | Lack of assurance of sterility | SUN PHARMACEUTICAL INDUSTRIES INC / 26892 vials | Class II | Terminated |
| D-0889-2022 | 05-06-2022 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: customer complaints exceeded respective action limits. | Noven Pharmaceuticals Inc / 274, 110 patches | Class II | Ongoing |
| D-0971-2022 | 05-05-2022 | Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90 Package NDCs: 72189-012-90; 72189-098-90; 72189-129-90; 72189-129-30; 72189-139-30; 72189-139-90; 72189-167-30; 72189-167-90 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Direct Rx / 81 bottles | Class II | Terminated |
| D-0970-2022 | 05-05-2022 | Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%) Antiseptic Mouthrise Plus, Antigingivitis/Antiplaque, Blue Mint, 1.5 Liter (50.7 FL OZ) bottle, Distributed By: Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 14800 9 | Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients. | Vi-Jon, LLC / 75,064 bottles | Class II | Terminated |
| D-0885-2022 | 05-04-2022 | Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | RemedyRepack Inc. / 22 bottles/90 count each | Class II | Terminated |
| D-0891-2022 | 05-03-2022 | Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Preferred Pharmaceuticals, Inc. / 31 bottles of 90 tables (Lot: K1721D); 5 bottles of 90 tablets (K1021E). | Class II | Terminated |
| D-0892-2022 | 05-03-2022 | Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Preferred Pharmaceuticals, Inc. / 47 Bottles of 30 Tabs (K1721E); 35 Bottles of 30 Tabs (H3021Q). | Class II | Terminated |
| D-0880-2022 | 05-03-2022 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01 | Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time. | American Health Packaging / 1603 cartons | Class III | Terminated |
| D-0881-2022 | 05-03-2022 | Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2 Package NDCs: 60505-6197-2 | Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint. | Apotex Corp. / 2353 bottles | Class III | Terminated |
| D-0855-2022 | 05-02-2022 | MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, Manufactured by Amgen Inc. Thousand Oaks, CA 91320-1799, NDC 55513-0206-01 | Defective container: loose crimp defect, potential loss of container integrity. | Amgen, Inc. / 15,823 | Class II | Terminated |
| D-0886-2022 | 05-02-2022 | Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | RemedyRepack Inc. / 26/90 count bottles = 2,340 tablets | Class II | Terminated |
| D-0887-2022 | 05-02-2022 | Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | RemedyRepack Inc. / 30 bottles/90 count = 2,700 tablets | Class II | Terminated |
| D-0890-2022 | 04-29-2022 | Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25 g) per tube, Active Ingredients: Oxtinoxate (7.5%), Oxybenzone (3%); Distributed by: Higher Education Skincare, 1.833.251.0388 | Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%. | Eco Lips, Inc / 17,000 units | Class III | Terminated |
| D-0857-2022 | 04-29-2022 | buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottle (47335-737-13), Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13 | Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle. | SUN PHARMACEUTICAL INDUSTRIES INC / 9804 bottles | Class III | Terminated |
| D-0858-2022 | 04-29-2022 | buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-738-86 Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13 | Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle. | SUN PHARMACEUTICAL INDUSTRIES INC / 744 bottles | Class III | Terminated |
| D-0844-2022 | 04-28-2022 | alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1. Package NDCs: 59762-0057-1; 59762-0059-1; 59762-0066-1; 59762-0068-1 | Failed Dissolution Specifications: low out-of-specification dissolution test results observed. | Viatris Inc / 6,789 bottles | Class II | Terminated |
| D-0854-2022 | 04-28-2022 | Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07. | Failed Dissolution Specifications: low out of specification results for dissolution. | Viatris Inc / 110 bottles | Class II | Terminated |
| D-0875-2022 | 04-27-2022 | GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19 Package NDCs: 43386-060-19 | Failed Stability Specification | Lupin Pharmaceuticals Inc. / 26,910 bottles | Class II | Terminated |
| D-0879-2022 | 04-27-2022 | Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30 lozenges, Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 96566-0009, UPC 0 79893 41266 5 | Subpotent drug: Low OOS for menthol content at the three month room temperature. | Bestco LLC / 2038 bags | Class III | Terminated |
| D-0831-2022 | 04-25-2022 | Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44 | CGMP Deviations | SCA Pharmaceuticals / 30 bags | Class II | Terminated |
| D-0830-2022 | 04-25-2022 | Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32 | CGMP Deviations | SCA Pharmaceuticals / 424 bags | Class II | Terminated |
| D-0829-2022 | 04-25-2022 | Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40 | CGMP Deviations | SCA Pharmaceuticals / 120 bags | Class II | Terminated |
| D-0791-2022 | 04-25-2022 | Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01 Package NDCs: 68462-128-01; 68462-128-05; 68462-129-01; 68462-129-05; 68462-130-01; 68462-130-05 | cGMP deviations | Glenmark Pharmaceuticals Inc., USA / 11,136 bottles | Class II | Completed |
| D-0792-2022 | 04-25-2022 | Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-129-01 Package NDCs: 68462-128-01; 68462-128-05; 68462-129-01; 68462-129-05; 68462-130-01; 68462-130-05 | cGMP deviations | Glenmark Pharmaceuticals Inc., USA / 12,003 bottles | Class II | Completed |
| D-0793-2022 | 04-25-2022 | Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Package NDCs: 68462-128-01; 68462-128-05; 68462-129-01; 68462-129-05; 68462-130-01; 68462-130-05 | cGMP deviations | Glenmark Pharmaceuticals Inc., USA / a) 7,044 bottles; b) 1,014 bottles | Class II | Completed |
| D-0874-2022 | 04-22-2022 | Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017 | CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. | Pfizer Inc. / 8346 bottles | Class II | Terminated |
| D-0873-2022 | 04-22-2022 | Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017 | CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. | Pfizer Inc. / 10,304 bottles | Class II | Terminated |
| D-0872-2022 | 04-22-2022 | Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017 | CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. | Pfizer Inc. / 2079 bottles | Class II | Terminated |
| D-0786-2022 | 04-21-2022 | TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, Hand Sanitizer Non-Sterile Solution, FDA Approved, 76590-8347-1, 3780 mL, 3.78 Liters (1 Gallon). Torco Race Fuels 2527 W. Dallas Ave. Apache Junction, AZ, 85120 | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | Torco Race Fuels / 127 gallons | Class II | Terminated |
| D-0847-2022 | 04-21-2022 | Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-998-67 | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program. | McKesson Corporation dba McKesson Drug Company / 13, 200 tubes | Class II | Ongoing |
| D-0850-2022 | 04-21-2022 | Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-65 | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program. | McKesson Corporation dba McKesson Drug Company / 55,440 tubes | Class II | Ongoing |
| D-0848-2022 | 04-21-2022 | Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64 | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program. | McKesson Corporation dba McKesson Drug Company / 81,757 bottles | Class II | Ongoing |
| D-0851-2022 | 04-21-2022 | Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-053-68 | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program. | McKesson Corporation dba McKesson Drug Company / 5,640 tubes | Class II | Ongoing |
| D-0849-2022 | 04-21-2022 | Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66 | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program. | McKesson Corporation dba McKesson Drug Company / 1176 tubes | Class II | Ongoing |
| D-0846-2022 | 04-15-2022 | Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04 | Failed viscosity specification - product was below specificcation | Akorn, Inc. / 66,744 bottles | Class III | Terminated |
| D-0832-2022 | 04-15-2022 | Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Package NDCs: 33342-044-10; 33342-044-12; 33342-044-07; 33342-044-44; 33342-045-10; 33342-045-12; 33342-045-07; 33342-045-44; 33342-046-10; 33342-046-12; 33342-046-07; 33342-046-44 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Macleods Pharma Usa Inc / 12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tablets | Class II | Terminated |
| D-0834-2022 | 04-15-2022 | Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Package NDCs: 33342-044-10; 33342-044-12; 33342-044-07; 33342-044-44; 33342-045-10; 33342-045-12; 33342-045-07; 33342-045-44; 33342-046-10; 33342-046-12; 33342-046-07; 33342-046-44 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Macleods Pharma Usa Inc / 3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets | Class II | Terminated |
| D-0853-2022 | 04-15-2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78. Package NDCs: 43598-560-79; 43598-560-78; 43598-561-79; 43598-561-78 | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 252 Blister Packs | Class II | Terminated |
| D-0833-2022 | 04-15-2022 | Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Package NDCs: 33342-044-10; 33342-044-12; 33342-044-07; 33342-044-44; 33342-045-10; 33342-045-12; 33342-045-07; 33342-045-44; 33342-046-10; 33342-046-12; 33342-046-07; 33342-046-44 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Macleods Pharma Usa Inc / 3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tablets | Class II | Terminated |
| D-0835-2022 | 04-15-2022 | Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Package NDCs: 33342-050-07; 33342-050-10; 33342-050-44; 33342-050-12; 33342-051-07; 33342-051-10; 33342-051-44; 33342-051-12; 33342-052-07; 33342-052-10; 33342-052-44; 33342-052-12 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Macleods Pharma Usa Inc / N/A | Class II | Terminated |
| D-0836-2022 | 04-15-2022 | Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Package NDCs: 33342-050-07; 33342-050-10; 33342-050-44; 33342-050-12; 33342-051-07; 33342-051-10; 33342-051-44; 33342-051-12; 33342-052-07; 33342-052-10; 33342-052-44; 33342-052-12 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Macleods Pharma Usa Inc / N/A | Class II | Terminated |
| D-0837-2022 | 04-15-2022 | Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Package NDCs: 33342-050-07; 33342-050-10; 33342-050-44; 33342-050-12; 33342-051-07; 33342-051-10; 33342-051-44; 33342-051-12; 33342-052-07; 33342-052-10; 33342-052-44; 33342-052-12 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Macleods Pharma Usa Inc / N/A | Class II | Terminated |
| D-1168-2022 | 04-15-2022 | Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704 | Subpotent drug | Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy / 950 mLs in 1x8 oz and 2x16 oz bottles. | Class I | Terminated |
| D-1167-2022 | 04-15-2022 | Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704, | Subpotent drug | Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy / 1,966 mLs in 12 oz; 2 oz; 16 oz and 6 oz bottles | Class I | Terminated |
| D-0794-2022 | 04-15-2022 | Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA | cGMP Deviations | Teva Pharmaceuticals USA Inc / 353964 units | Class II | Terminated |
| D-0878-2022 | 04-14-2022 | Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16 | Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content | Monarch PCM, LLC / 15,730 bottles | Class III | Terminated |
| D-1051-2022 | 04-13-2022 | Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial Diluent for Glucagon, 1ml syringe, Rx only, MFG: Eli Lilly, NDC 0002-8031-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 13 syringes | Class II | Terminated |
| D-1014-2022 | 04-13-2022 | Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma NDC 49502-101-02 Package NDCs: 49502-102-01; 49502-102-02; 49502-101-01; 49502-101-02 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 30 packs | Class II | Terminated |
| D-1012-2022 | 04-13-2022 | EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma, NDC 49502-501-02 Package NDCs: 49502-500-01; 49502-500-02; 49502-500-92; 49502-501-01; 49502-501-02; 49502-501-92 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 4 cartons/2 auto injectors each | Class II | Terminated |
