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 10, 2025 and include a total of 17129 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0843-2019 | 07-20-2018 | Dr. King's SafeCare Rx Swollen Glands Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955012122, NDC 57955-0121-2 | Microbial contamination | King Bio Inc. / 107 bottles | Class I | Terminated |
| D-0837-2019 | 07-20-2018 | Dr. King's SafeCare Rx Hair & Nails Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955004929, NDC 57955-0049-2 | Microbial contamination | King Bio Inc. / 230 bottles | Class I | Terminated |
| D-0880-2019 | 07-20-2018 | Dr. King's SafeCare Rx Verbal Anger, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955106029, NDC 57955-1061-2 | Microbial contamination | King Bio Inc. / 71 bottles | Class I | Terminated |
| D-0692-2019 | 07-20-2018 | Dr. King's Natural Medicine Warming Arthritic Pain & Joint Relief Homeopathic Cream, Net Wt. 3 oz. (85 g), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955093534, NDC 57955-0935-3 | Microbial contamination | King Bio Inc. / 223 tubes | Class I | Terminated |
| D-0727-2019 | 07-20-2018 | Dr. King's SafeCare Rx Asthma Clear Allergy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955004424, NDC 57955-0044-2 | Microbial contamination | King Bio Inc. / 797 bottles | Class I | Terminated |
| D-0567-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Acne Clear, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955504122, NDC 57955-5041-2 | Microbial contamination | King Bio Inc. / 9068 bottles | Class I | Terminated |
| D-0684-2019 | 07-20-2018 | Dr. King's SafeCare Rx Children's Growth & Development Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955014225, NDC 57955-0148-2 | Microbial contamination | King Bio Inc. / 98 bottles | Class I | Terminated |
| D-0795-2019 | 07-20-2018 | Dr. King's SafeCare Rx Envious, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955252023, NDC 57955-2523-2 | Microbial contamination | King Bio Inc. / 16 bottles | Class I | Terminated |
| D-0910-2019 | 07-20-2018 | Safecare+ Northeast Regional Allergies Non-Drowsy Homeopathic Taste-Free, Oral Spray, 1 fl oz (29.6 mL), UPC 357955832515, NDC 57955-8325-1 | Microbial contamination | King Bio Inc. / 0 | Class I | Terminated |
| D-0802-2019 | 07-20-2018 | Dr. King's SafeCare Rx Bug Away, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955007722, NDC 57955-0077-2 | Microbial contamination | King Bio Inc. / 345 bottles | Class I | Terminated |
| D-0747-2019 | 07-20-2018 | Dr. King's SafeCare Rx Alcoholism Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955302025, NDC 57955-3021-2 | Microbial contamination | King Bio Inc. / 41 bottles | Class I | Terminated |
| D-0558-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Back, Muscle & Joint Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955516125, NDC 57955-6161-2 | Microbial contamination | King Bio Inc. / 4507 bottles | Class I | Terminated |
| D-0750-2019 | 07-20-2018 | Dr. King's SafeCare Rx Sexual Identity Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955127024, NDC 57955-1271-2 | Microbial contamination | King Bio Inc. / 2 bottles | Class I | Terminated |
| D-0948-2019 | 07-20-2018 | NET Remedies #2 Metal Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4202-2 | Microbial contamination | King Bio Inc. / 16495 bottles | Class I | Terminated |
| D-0548-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Sinus Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955513421, NDC 57955-5134-2 | Microbial contamination | King Bio Inc. / 16184 bottles | Class I | Terminated |
| D-0712-2019 | 07-20-2018 | Dr. King's SafeCare Rx Colds & Flu Immune, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955038221, NDC 57955-0382-2 | Microbial contamination | King Bio Inc. / 834 bottles | Class I | Terminated |
| D-0981-2019 | 07-20-2018 | Dr. King's Natural Medicine Good Mood Enhancer Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955515029, NDC 57955-8150-2 | Microbial contamination | King Bio Inc. / 4612 bottles | Class I | Terminated |
| D-0633-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Additive & Preservative Detox, 2 fl. oz. (59 mL), King Bio, Inc. 3 Westside Dr. Asheville, NC 28806, UPC 357955540526, NDC 57955-6206-2 | Microbial contamination | King Bio Inc. / 66 bottles | Class I | Terminated |
| D-0609-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Hair & Nails Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955504924, NDC 57955-5049-2 | Microbial contamination | King Bio Inc. / 210 bottles | Class I | Terminated |
| D-0928-2019 | 07-20-2018 | NET Remedies #11 (Lilac Label) Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer: King Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428 Hume Street, Toowoomba QLD 4350, Australia | Microbial contamination | King Bio Inc. / 599 bottles | Class I | Terminated |
| D-0840-2019 | 07-20-2018 | Dr. King's SafeCare Rx Prejudiced, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955100027, NDC 57955-2322-2 | Microbial contamination | King Bio Inc. / 4 bottles | Class I | Terminated |
| D-0736-2019 | 07-20-2018 | Dr. King's SafeCare Rx Migraine Freee..., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955002826, NDC 57955-0028-2 | Microbial contamination | King Bio Inc. / 138 bottles | Class I | Terminated |
| D-0561-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Urinary Tract Irritations, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955505228, NDC 57955-5062-2 | Microbial contamination | King Bio Inc. / 1443 bottles | Class I | Terminated |
| D-0832-2019 | 07-20-2018 | Dr. King's SafeCare Rx Allergies: Food Chemicals U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955004226, NDC 57955-0042-2 | Microbial contamination | King Bio Inc. / 694 bottles | Class I | Terminated |
| D-0825-2019 | 07-20-2018 | Dr. King's SafeCare Rx Hemorrhoid Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955002321, NDC 57955-0023-2 | Microbial contamination | King Bio Inc. / 145 bottles | Class I | Terminated |
| D-0711-2019 | 07-20-2018 | Dr. King's SafeCare Rx Fever Reliever Immune, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955016021, NDC 57955-0272-2 | Microbial contamination | King Bio Inc. / 46 bottles | Class I | Terminated |
| D-0637-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Snore Control, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955512028, NDC 57955-5120-2 | Microbial contamination | King Bio Inc. / 14781 bottles | Class I | Terminated |
| D-0522-2019 | 07-20-2018 | Dr. King's Lymph Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955506324, NDC 57955-5063-2 | Microbial contamination | King Bio Inc. / 6446 bottles | Class I | Terminated |
| D-0944-2019 | 07-20-2018 | NET Remedies #9 ER 911 Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4209-2 | Microbial contamination | King Bio Inc. / 38399 bottles | Class I | Terminated |
| D-0966-2019 | 07-20-2018 | Dr. King's Natural Medicine Regional Allergies Canadian Prairies, 59 mL (liquid/liquide), DIN-HM 80074815 UPC 357955181729 | Microbial contamination | King Bio Inc. / 710 bottles | Class I | Terminated |
| D-0947-2019 | 07-20-2018 | NET Remedies #12 Flu Immune Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4212-2 | Microbial contamination | King Bio Inc. / 13198 bottles | Class I | Terminated |
| D-0649-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Water Chemical Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955540021, NDC 57955-6100-2 | Microbial contamination | King Bio Inc. / 13 bottles | Class I | Terminated |
| D-0925-2019 | 07-20-2018 | NET Remedies #9 Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer: King Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428 Hume Street, Toowoomba QLD 4350, Australia | Microbial contamination | King Bio Inc. / 6400 bottles | Class I | Terminated |
| D-0884-2019 | 07-20-2018 | Dr. King's SafeCare Rx Allergies: Fruits & Vegetables, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955250128, NDC 57955-2501-2 | Microbial contamination | King Bio Inc. / 61 bottles | Class I | Terminated |
| D-0592-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Swollen Glands Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955512127, NDC 57955-5121-2 | Microbial contamination | King Bio Inc. / 274 bottles | Class I | Terminated |
| D-0867-2019 | 07-20-2018 | Dr. King's SafeCare Rx Mental Alertness For Seniors, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955156024, NDC 57955-1561-2 | Microbial contamination | King Bio Inc. / 201 bottles | Class I | Terminated |
| D-0826-2019 | 07-20-2018 | Dr. King's SafeCare Rx Spaced Out, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955154020, NDC 57955-1541-2 | Microbial contamination | King Bio Inc. / 32 bottles | Class I | Terminated |
| D-0719-2019 | 07-20-2018 | Dr. King's SafeCare Rx GallPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955006824, NDC 57955-0340-2 | Microbial contamination | King Bio Inc. / 217 bottles | Class I | Terminated |
| D-0808-2019 | 07-20-2018 | Dr. King's SafeCare Rx Insecurity, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955256021, NDC 57955-2561-2 | Microbial contamination | King Bio Inc. / 70 bottles | Class I | Terminated |
| D-0724-2019 | 07-20-2018 | Dr. King's SafeCare Rx Indecision Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955277026, NDC 57955-2771-2 | Microbial contamination | King Bio Inc. / 22 bottles | Class I | Terminated |
| D-0722-2019 | 07-20-2018 | Dr. King's SafeCare Rx Head Colds Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955028222, NDC 57955-0282-2 | Microbial contamination | King Bio Inc. / 108 bottles | Class I | Terminated |
| D-0762-2019 | 07-20-2018 | Dr. King's SafeCare Rx TremorPlex U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955003328, NDC 57955-0033-2 | Microbial contamination | King Bio Inc. / 289 bottles | Class I | Terminated |
| D-0850-2019 | 07-20-2018 | Dr. King's SafeCare Rx Tinnitus Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955027522, NDC 57955-0275-2 | Microbial contamination | King Bio Inc. / 518 bottles | Class I | Terminated |
| D-0735-2019 | 07-20-2018 | Dr. King's SafeCare Rx Allergies Animal Hair & Dander Allergy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955219620, NDC 57955-2196-2 | Microbial contamination | King Bio Inc. / 143 bottles | Class I | Terminated |
| D-0927-2019 | 07-20-2018 | NET Remedies #10 (Maroon Label) Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer: King Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428 Hume Street, Toowoomba QLD 4350, Australia | Microbial contamination | King Bio Inc. / 403 bottles | Class I | Terminated |
| D-0954-2019 | 07-20-2018 | NET Remedies #4 Wood Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4204-2 | Microbial contamination | King Bio Inc. / 21870 bottles | Class I | Terminated |
| D-0853-2019 | 07-20-2018 | Dr. King's SafeCare Rx Self-Abuse, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955107026, NDC 57955-1071-2 | Microbial contamination | King Bio Inc. / 104 bottles | Class I | Terminated |
| D-0890-2019 | 07-20-2018 | Dr. King's SafeCare Rx EMF Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955040026, NDC 57955-0420-2 | Microbial contamination | King Bio Inc. / 130 bottles | Class I | Terminated |
| D-0923-2019 | 07-20-2018 | NET Remedies #7 Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer: King Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428 Hume Street, Toowoomba QLD 4350, Australia | Microbial contamination | King Bio Inc. / 1700 bottles | Class I | Terminated |
| D-0897-2019 | 07-20-2018 | Dr. King's SafeCare Rx Athlete's Foot Fighter, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955012924, NDC 57955-0129-2 | Microbial contamination | King Bio Inc. / 46 bottles | Class I | Terminated |
| D-0847-2019 | 07-20-2018 | Dr. King's SafeCare Rx First Aid for Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955177029, NDC 57955-1770-2 | Microbial contamination | King Bio Inc. / 1229 bottles | Class I | Terminated |
| D-0603-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Nausea & Motion Sickness, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955505525, NDC 57955-5055-2 | Microbial contamination | King Bio Inc. / 1663 bottles | Class I | Terminated |
| D-0874-2019 | 07-20-2018 | Dr. King's SafeCare Rx Aller-Detox: Cosmetics & Household, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955240327, NDC 57955-2407-2 | Microbial contamination | King Bio Inc. / 27 bottles | Class I | Terminated |
| D-0772-2019 | 07-20-2018 | Dr. King's SafeCare Rx CS-Rectal Bowel, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955021827, NDC 57955-0218-2 | Microbial contamination | King Bio Inc. / 94 bottles | Class I | Terminated |
| D-0946-2019 | 07-20-2018 | NET Remedies #7 Flora Plus Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4207-2 | Microbial contamination | King Bio Inc. / 9888 bottles | Class I | Terminated |
| D-0714-2019 | 07-20-2018 | Dr. King's SafeCare Rx Anti-Aging & Wrinkles For Women, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955614722, NDC 57955-6148-2 | Microbial contamination | King Bio Inc. / 338 bottles | Class I | Terminated |
| D-0635-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Total Body Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955536123, NDC 57955-5361-2 | Microbial contamination | King Bio Inc. / 1393 bottles | Class I | Terminated |
| D-0953-2019 | 07-20-2018 | NET Remedies #3 Water Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4203-2 | Microbial contamination | King Bio Inc. / 15898 bottles | Class I | Terminated |
| D-0962-2019 | 07-20-2018 | Dr. King's Natural Medicine Aquaflora Candida High Potency 9 Multi-Strain Candida Formula, 236 mL, (liquid/liquide), Manufactured by:/Fabrique par: King Bio, Inc. 3 Westside Dr., Asheville, NC 28805 USA Import by: Importe par: Ambiental Solutions Inc. Vancouver, BC, V5Y 1E6, DIN-HM 80036805 UPC 357955180289 | Microbial contamination | King Bio Inc. / 10418 bottles | Class I | Terminated |
| D-0740-2019 | 07-20-2018 | Dr. King's SafeCare Rx Better Breath Oral Health, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955630128, NDC 57955-6302-2 | Microbial contamination | King Bio Inc. / 12 bottles | Class I | Terminated |
| D-0720-2019 | 07-20-2018 | Dr. King's SafeCare Rx Back, Neck, Muscle & Joint Injuries, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955016120, NDC 57955-0261-2 | Microbial contamination | King Bio Inc. / 1018 bottles | Class I | Terminated |
| D-0971-2019 | 07-20-2018 | Dr. King's SafeCare Rx Allergies Pacific U.S. Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955260820, NDC 57955-2717-2 | Microbial contamination | King Bio Inc. / 422 bottles | Class I | Terminated |
| D-1019-2018 | 07-18-2018 | Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01. Package NDCs: 31722-542-30; 31722-542-01; 31722-542-05; 31722-542-10; 31722-543-30; 31722-543-01; 31722-543-05; 31722-543-10 | Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules. | Hetero Labs, Ltd. - Unit III / 18,288 bottles | Class II | Terminated |
| D-1175-2018 | 07-18-2018 | AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Avkare Incorporated / 19109 bottles | Class II | Terminated |
| D-1176-2018 | 07-18-2018 | AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Avkare Incorporated / 12950 bottles | Class II | Terminated |
| D-1173-2018 | 07-18-2018 | AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Avkare Incorporated / 12240 bottles | Class II | Terminated |
| D-1017-2018 | 07-18-2018 | Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-408-01. Package NDCs: 42543-406-01; 42543-407-01; 42543-408-01 | Failed Tablet/Capsule Specifications: Tablet breakage | VENSUN PHARMACEUTICALS INC / 11,652 bottles | Class II | Terminated |
| D-0967-2018 | 07-18-2018 | Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | MAJOR PHARMACEUTICALS / 4,556 cartons | Class II | Terminated |
| D-0966-2018 | 07-18-2018 | Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | MAJOR PHARMACEUTICALS / 5,464 cartons | Class II | Terminated |
| D-1177-2018 | 07-18-2018 | AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Avkare Incorporated / 19623 bottles | Class II | Terminated |
| D-1174-2018 | 07-18-2018 | AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-885-90 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Avkare Incorporated / 24796 bottles | Class II | Terminated |
| D-1018-2018 | 07-18-2018 | Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-407-01. Package NDCs: 42543-406-01; 42543-407-01; 42543-408-01 | Failed Tablet/Capsule Specifications: Tablet breakage | VENSUN PHARMACEUTICALS INC / 3,683 bottles | Class II | Terminated |
| D-1097-2018 | 07-18-2018 | Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Northwind Pharmaceuticals LLC / 2 bottles | Class II | Terminated |
| D-1096-2018 | 07-18-2018 | Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Northwind Pharmaceuticals LLC / 43 bottles | Class II | Terminated |
| D-1095-2018 | 07-18-2018 | Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Northwind Pharmaceuticals LLC / 68 bottles | Class II | Terminated |
| D-1098-2018 | 07-18-2018 | Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Northwind Pharmaceuticals LLC / 14 bottles | Class II | Terminated |
| D-1110-2018 | 07-17-2018 | Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | A-S Medication Solutions LLC. / 524 bottles | Class II | Ongoing |
| D-1111-2018 | 07-17-2018 | Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | A-S Medication Solutions LLC. / 531 bottles | Class II | Ongoing |
| D-1108-2018 | 07-17-2018 | Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | A-S Medication Solutions LLC. / 666 bottles | Class II | Ongoing |
| D-1109-2018 | 07-17-2018 | Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | A-S Medication Solutions LLC. / 178 bottles | Class II | Ongoing |
| D-1049-2018 | 07-17-2018 | Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211. | CGMP Deviations | Longbow First Aid Products Manufactory / 14,400 bottles | Class II | Terminated |
| D-1048-2018 | 07-17-2018 | Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC 7110500002, and b) 0.67 fl (20 ml) NDC 71150000) bottles, Manufactured for: Redicare LLC, Congers, NY | CGMP Deviations | Longbow First Aid Products Manufactory / 30,000 bottles | Class II | Terminated |
| D-1021-2018 | 07-17-2018 | Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | RemedyRepack Inc. / 3 HDPE 90-count bottles (270 tablets) | Class II | Terminated |
| D-1020-2018 | 07-17-2018 | Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | RemedyRepack Inc. / 4 HDPE 90-count bottles (360 tablets) | Class II | Terminated |
| D-0984-2018 | 07-16-2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 64,168 bottles | Class II | Ongoing |
| D-0985-2018 | 07-16-2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 164,922 bottles | Class II | Ongoing |
| D-0983-2018 | 07-16-2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2317-19. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 99,554 bottles | Class II | Ongoing |
| D-0981-2018 | 07-16-2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, NDC 0591-2315-19. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 56,603 bottles | Class II | Ongoing |
| D-0982-2018 | 07-16-2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2316-19. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 195,234 bottles | Class II | Ongoing |
| D-0987-2018 | 07-16-2018 | Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 30,793 90-count bottles, 1,158 1000-count bottles | Class II | Ongoing |
| D-0989-2018 | 07-16-2018 | Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 13,555 90-count bottles; 2,892 500-count bottles | Class II | Ongoing |
| D-0986-2018 | 07-16-2018 | Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 8,046 30-count bottles, 20,841 90-count bottles | Class II | Ongoing |
| D-0988-2018 | 07-16-2018 | Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Teva Pharmaceuticals USA / 15,347 90-count bottles, 8,378 1000-count bottles | Class II | Ongoing |
| D-1074-2018 | 07-16-2018 | Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89 | API material used in the manufacturing of the product did not receive regulatory approval prior to release. | Teva Pharmaceuticals USA / 13,715 120-count bottles | Class II | Terminated |
| D-0971-2018 | 07-13-2018 | Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-370-09 Package NDCs: 43547-367-03; 43547-367-09; 43547-367-50; 43547-367-11; 43547-368-03; 43547-368-09; 43547-368-50; 43547-368-11; 43547-369-03; 43547-369-09; 43547-369-50; 43547-369-11; 43547-370-03; 43547-370-09; 43547-370-50; 43547-370-11 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0969-2018 | 07-13-2018 | Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-368-09 Package NDCs: 43547-367-03; 43547-367-09; 43547-367-50; 43547-367-11; 43547-368-03; 43547-368-09; 43547-368-50; 43547-368-11; 43547-369-03; 43547-369-09; 43547-369-50; 43547-369-11; 43547-370-03; 43547-370-09; 43547-370-50; 43547-370-11 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0975-2018 | 07-13-2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-314-09 Package NDCs: 43547-311-03; 43547-311-09; 43547-311-50; 43547-312-03; 43547-312-09; 43547-312-50; 43547-313-03; 43547-313-09; 43547-313-50; 43547-314-03; 43547-314-09; 43547-314-50; 43547-315-03; 43547-315-09; 43547-315-50 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0976-2018 | 07-13-2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-315-09 Package NDCs: 43547-311-03; 43547-311-09; 43547-311-50; 43547-312-03; 43547-312-09; 43547-312-50; 43547-313-03; 43547-313-09; 43547-313-50; 43547-314-03; 43547-314-09; 43547-314-50; 43547-315-03; 43547-315-09; 43547-315-50 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0973-2018 | 07-13-2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-312-09 Package NDCs: 43547-311-03; 43547-311-09; 43547-311-50; 43547-312-03; 43547-312-09; 43547-312-50; 43547-313-03; 43547-313-09; 43547-313-50; 43547-314-03; 43547-314-09; 43547-314-50; 43547-315-03; 43547-315-09; 43547-315-50 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0970-2018 | 07-13-2018 | Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-369-09 Package NDCs: 43547-367-03; 43547-367-09; 43547-367-50; 43547-367-11; 43547-368-03; 43547-368-09; 43547-368-50; 43547-368-11; 43547-369-03; 43547-369-09; 43547-369-50; 43547-369-11; 43547-370-03; 43547-370-09; 43547-370-50; 43547-370-11 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
