Drug and pharmaceutical recalls
17732 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2015-10-28FDA-DrugHospira Inc.Class IIIAmidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29
Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
- 2015-10-28FDA-DrugRx PAKClass IIIDonnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx only, Manufactured for Concordia Pharmaceuticals, Inc., St. Michael, Barbados BB11005, Manufactured by IriSys, LLC San Diego, CA 92121, Repackaged by: RxPak, Div. of McKesson, Memphis, TN 38141, NDC 59212-425-10
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
- 2015-10-21FDA-DrugBedford PharmacyClass IIP-P (COBAL) 300-30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Lack of assurance of sterility
- 2015-10-21FDA-DrugBedford PharmacyClass IIP-P (COBAL)30-0.5/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Lack of assurance of sterility
- 2015-10-21FDA-DrugBedford PharmacyClass IIP-P-P (COBAL) 30-2- 30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Lack of assurance of sterility
- 2015-10-21FDA-DrugBedford PharmacyClass IIP-P-P (COBAL) 30-4-40/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Lack of assurance of sterility
- 2015-10-21FDA-DrugBedford PharmacyClass IIP-P-P (COBAL) 30-1-5/mL, Injection,Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Lack of assurance of sterility
- 2015-10-21FDA-DrugBedford PharmacyClass IITestosterone Cypionate (Complete Formula) 200 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Lack of assurance of sterility
- 2015-10-21FDA-DrugBedford PharmacyClass IITestosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Lack of assurance of sterility
- 2015-10-21FDA-DrugBedford PharmacyClass IIAcetylcysteine 10% Opthalmic Solution, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Lack of assurance of sterility
- 2015-10-21FDA-DrugBedford PharmacyClass IIHydroxocobalamin 20 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Lack of assurance of sterility
- 2015-10-21FDA-DrugBedford PharmacyClass IIMethylcobalamin (Bacteriostatic) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Lack of assurance of sterility
- 2015-10-21FDA-DrugBedford PharmacyClass IIP-P (COBAL) 30-2 /mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Lack of assurance of sterility
- 2015-10-21FDA-DrugBedford PharmacyClass IIP-P-P (COBAL) 30-1-20/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Lack of assurance of sterility
- 2015-10-21FDA-DrugBedford PharmacyClass IIMethylcobalamin (preservative Free) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Lack of assurance of sterility
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIIMeijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI 49544. NDC 41250-527-31, UPC 7 6023662291 8
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIIWal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIISunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIIUp&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis, MN 55403; NDC 11673-527-31, UPC 3 5166052731 5
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIITopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIISafeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b) 30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA 94566
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIIPremier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIIOhm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 51660-527-31, UPC 3 5166052731 5
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIIMajor loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIILeader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIIHEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIIHealth Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by: McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0073-1, UPC 0 5256913369 9
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIIGood Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box, NDC 24385-0161-52, ABC # 042-226, UPC 0 8770140650 8; b) For adults 10-count tablets, NDC 46122-0140-52, ABC# 059-535, UPC 0877014065546, Distributed by: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIIFred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIIEqualine Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41163-528-69, UPC 0 4116347138 2; and b) 30-count tablets per box, NDC 41163-528-31, UPC 0 4116346654 8; Distributed by: Supervalu Inc. Eden Prarie, MN 55344 USA
Superpotent Drug: Out Of Specification (OOS) result for Assay.
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