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-1290-2015 | 06-26-2015 | S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 98 mL | Class II | Terminated |
| D-1293-2015 | 06-26-2015 | SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2896-05 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 23 mL | Class II | Terminated |
| D-1235-2015 | 06-26-2015 | Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons. Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217. NDC: 68084-606-21. | Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. | American Health Packaging / 341 Cartons | Class III | Terminated |
| D-1289-2015 | 06-26-2015 | S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1962-40 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 64 mL | Class II | Terminated |
| D-1313-2015 | 06-26-2015 | SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / N/A | Class II | Terminated |
| D-1291-2015 | 06-26-2015 | SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 1200.4 mL | Class II | Terminated |
| D-1297-2015 | 06-26-2015 | SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1802-97 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 378 mL | Class II | Terminated |
| D-1314-2015 | 06-26-2015 | SIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 10 mL | Class II | Terminated |
| D-1292-2015 | 06-26-2015 | S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1701-19 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 25.3 mL | Class II | Terminated |
| D-1316-2015 | 06-26-2015 | S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 750 mL | Class II | Terminated |
| D-1288-2015 | 06-26-2015 | Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31. Package NDCs: 10631-115-69; 10631-115-31; 10631-116-69; 10631-116-31; 10631-117-69; 10631-117-31; 10631-118-69; 10631-118-31; 10631-133-69; 10631-133-31; 10631-134-69; 10631-134-31; 10631-002-31; 10631-003-31; 10631-004-31; 10631-005-31; 10631-006-31; 10631-007-31 | Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell. | Ranbaxy Inc. / 9,229 Boxes | Class II | Terminated |
| D-1296-2015 | 06-26-2015 | SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 70 mL | Class II | Terminated |
| D-1306-2015 | 06-26-2015 | SIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2913-85 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 10 mL | Class II | Terminated |
| D-1312-2015 | 06-26-2015 | SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 40 mL | Class II | Terminated |
| D-1307-2015 | 06-26-2015 | SIU-Tri-Mix 24/1/20 Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1747-39 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 5 mL | Class II | Terminated |
| D-1303-2015 | 06-26-2015 | SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1563-48 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 55 mL | Class II | Terminated |
| D-1315-2015 | 06-26-2015 | SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 34 mL | Class II | Terminated |
| D-1304-2015 | 06-26-2015 | SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2007-70 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 2.5 mL | Class II | Terminated |
| D-1299-2015 | 06-26-2015 | SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-01 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 2.5 mL | Class II | Terminated |
| D-1831-2015 | 06-26-2015 | METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01. | Defective Container: Lids on unit dose cups are not fully qualified. | VistaPharm, Inc. / 84,100 Cups | Class III | Terminated |
| D-1283-2015 | 06-24-2015 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02 Package NDCs: 0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02 | Failed Impurities/Degradation Specifications: out of specification for unknown impurity | Teva Pharmaceuticals USA / 19,504 bottles | Class II | Terminated |
| D-1231-2015 | 06-23-2015 | CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS ROYAL pharmacy II, 4909 W Park Blvd, Suite 177, Plano, TX 75093 --- NDC 88888-0043-31 | Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications. | Abrams Royal Pharmacy II, LLC / 30 count: 5 Bottles; 90 count: 2 Bottles | Class III | Terminated |
| D-1285-2015 | 06-23-2015 | Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by Actavis Pharma, Inc. Parsippany, NJ 07054 USA. NDC: 0591-2464-01. | Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. | Actavis Laboratories, FL, Inc. / 11,445 Bottles | Class III | Terminated |
| D-0385-2016 | 06-22-2015 | c-Budesonide 0.6MG capsules, 60-count bottle, NOT FOR ORAL USE-USE IN NASAL RINSE OR NEBULIZER, SOLUTIONS Rx PHARMACY, 2705 4TH AVENUE SOUTH, BIRMINGHAM, AL 35233 | Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules. | Solutions Rx Pharmacy / 11,712 capsules | Class II | Terminated |
| D1151-2015 | 06-18-2015 | Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811. NDC 0603-3432-21. | Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution. | Qualitest Pharmaceuticals / 2016 bottles | Class III | Terminated |
| D-1399-2015 | 06-15-2015 | Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 5 vials | Class II | Terminated |
| D-1386-2015 | 06-15-2015 | Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 2 vials | Class II | Terminated |
| D-1389-2015 | 06-15-2015 | Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 1 bottle | Class II | Terminated |
| D-1380-2015 | 06-15-2015 | Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 6 syringes | Class II | Terminated |
| D-1398-2015 | 06-15-2015 | Phenol 6% Injectable, 30 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 2 vials | Class II | Terminated |
| D-1401-2015 | 06-15-2015 | Doxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 30 bags | Class II | Terminated |
| D-1382-2015 | 06-15-2015 | Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 5 vials | Class II | Terminated |
| D-1402-2015 | 06-15-2015 | Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 6 vials | Class II | Terminated |
| D-1404-2015 | 06-15-2015 | Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 6 vials | Class II | Terminated |
| D-1391-2015 | 06-15-2015 | 17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 85 vials | Class II | Terminated |
| D-1385-2015 | 06-15-2015 | Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 4 vials | Class II | Terminated |
| D-1396-2015 | 06-15-2015 | Morphine/0.9 % NaCl 1 mg/mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 4 bags | Class II | Terminated |
| D-1383-2015 | 06-15-2015 | Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 4 vials | Class II | Terminated |
| D-1392-2015 | 06-15-2015 | Hydroxocobalamin (Preserved) 10,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 15 vials | Class II | Terminated |
| D-1393-2015 | 06-15-2015 | Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 2 vials | Class II | Terminated |
| D-1387-2015 | 06-15-2015 | Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 3 bottles | Class II | Terminated |
| D-1388-2015 | 06-15-2015 | Doxcycline/0.9% NaCl 150 mg/150 mL IV, 150 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 88 bags | Class II | Terminated |
| D-1395-2015 | 06-15-2015 | Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 22 vials | Class II | Terminated |
| D-1384-2015 | 06-15-2015 | Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 2 vials | Class II | Terminated |
| D-1397-2015 | 06-15-2015 | Glycerin (v/v) 72% Injection, 25 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 1 vial | Class II | Terminated |
| D-1394-2015 | 06-15-2015 | Doxycycline/0.9% NaCl 150 mg/250 mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 112 bags | Class II | Terminated |
| D-1400-2015 | 06-15-2015 | Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 6 vials | Class II | Terminated |
| D-1403-2015 | 06-15-2015 | Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 5 vials | Class II | Terminated |
| D-1381-2015 | 06-15-2015 | Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 2 vials | Class II | Terminated |
| D-1390-2015 | 06-15-2015 | Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 58 bags | Class II | Terminated |
| D-1330-2015 | 06-12-2015 | PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8. | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug. | GC Natural Nutrition, Inc. / 12,000-15,000 bottles (estimated) | Class I | Terminated |
| D-1141-2015 | 06-10-2015 | NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, Manufactured for AstraZeneca LLC, Wilmington, Distributed by AstraZeneca, AB, Sodertalje, Sweden. NDC 00186-5020-31. | Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets. | AstraZeneca Pharmaceuticals LP / 34,524 bottles | Class II | Terminated |
| D-1150-2015 | 06-10-2015 | OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by Nesher Pharmaceuticals USA LLC., St. Louis, MO 63044, Distributed by Major Pharmaceuticals, Livonia, MI 48150, NDC 0904-6444-61. | Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets. | The Harvard Drug Group, LLC / 12,717 tablets | Class II | Terminated |
| D-1054-2016 | 06-10-2015 | Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. | Vital Care Compounder / 39 vials | Class II | Terminated |
| D-1055-2016 | 06-10-2015 | Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. | Vital Care Compounder / 9 Vials | Class II | Terminated |
| D-1056-2016 | 06-10-2015 | Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. | Vital Care Compounder / 54 vials | Class II | Terminated |
| D-0508-2016 | 06-08-2015 | HUMAN CHORIONIC GONADOTROPIC (HCG) Sublingual Drops, 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-0498-2016 | 06-08-2015 | BI-EST Lozenges, 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-0499-2016 | 06-08-2015 | BI-EST Suspensions, 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-0504-2016 | 06-08-2015 | TRI-EST 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-0500-2016 | 06-08-2015 | BI-EST Creams, 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-0487-2016 | 06-08-2015 | E3 CREAM, 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-0502-2016 | 06-08-2015 | TRI-EST Lozenges, 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-0507-2016 | 06-08-2015 | HUMAN CHORIONIC GONADOTROPIC (HCG) 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-0503-2016 | 06-08-2015 | TRI-EST Liquids, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / | Class II | Terminated |
| D-0486-2016 | 06-08-2015 | 2-DEOXY-D-GLUCOSE Powder, 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-0493-2016 | 06-08-2015 | ESTRIOL Face Creams, 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-0489-2016 | 06-08-2015 | ESTRIOL 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-0492-2016 | 06-08-2015 | ESTRIOL Vaginal 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-0490-2016 | 06-08-2015 | ESTRIOL Vaginal Creams, 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-0494-2016 | 06-08-2015 | ESTRIOL Creams, 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-0497-2016 | 06-08-2015 | BI-EST 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-0505-2016 | 06-08-2015 | METHYLFOLATE 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-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-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-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-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-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-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-1708-2015 | 06-02-2015 | Morphine 50 mg/ml + Fentanyl 2,000 mcg/ml + Bupivacaine 10 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 / 86 ml | 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-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-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-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-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-1572-2015 | 06-02-2015 | Methylcobalamin 5,000 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 / 33 ml total | Class II | Terminated |
| D-1509-2015 | 06-02-2015 | HCG 1,100 IU/ml + Methylcobalamin 0.5 mg/ml Injection, 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 / 161 ml total volume | Class II | Terminated |
| D-1494-2015 | 06-02-2015 | Fentanyl 2,000 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-1454-2015 | 06-02-2015 | Clotrimazole 2% Otic Suspension, ml, Sterile, Room Temperature, Shake Well, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 29 mL Total volume | Class II | Terminated |
| D-1703-2015 | 06-02-2015 | Morphine 45 mg/ml + Bupivacaine 8 mg/ml + Baclofen 25 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 / 66 ml | Class II | Terminated |
| D-1606-2015 | 06-02-2015 | Morphine 45 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 / 23 ml total volume | Class II | Terminated |
| D-1738-2015 | 06-02-2015 | Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America / 43 ml | Class II | Terminated |
