Class I - Dangerous
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, Distributed by: Wal-Mart, Bentonville, AR 72716. NDC 68645-545-59
Legacy Pharmaceutical Packaging
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Class I - Dangerous
CGMP Deviations
Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch, 100-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-9283-01
Preferred Pharmaceuticals
Class I - Dangerous
CGMP Deviations
Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyronine (T3) 13.5mcg/Levothyroxine (T4) 57mcg, 90-count bottles, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-7605-09
Preferred Pharmaceuticals
Class I - Dangerous
CGMP Deviations
Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.
The Protein Shoppe
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.
Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5mcg, 90-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-6860-09
Preferred Pharmaceuticals
Class I - Dangerous
CGMP Deviations
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, NC NDC 51754-2001-4
Exela Pharma Sciences
Class I - Dangerous
Short Fill
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class I - Dangerous
Subpotent Drug: FDA analysis found product to be subpotent
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.