December 23, 2020DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by: Rite Aid,
Hazard: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
December 23, 2020DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The Kroger CO,
Hazard: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
December 23, 2020DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 OZ (15g), Distributed by The Kroger Co.
Hazard: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
December 23, 2020DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceutical
Hazard: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
December 23, 2020DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.5 oz. (14.2 g), Made with Pride & Care for
Hazard: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
December 23, 2020DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2g), NDC 49035-812-01, b
Hazard: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
December 23, 2020DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharma
Hazard: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
December 23, 2020DrugsFDA
BASF Corporation recalls Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE
Hazard: Cross contamination: the excipient was found to be contaminated with theophylline.
December 23, 2020DrugsFDA
Biogen MA Inc. recalls Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx
Hazard: Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
December 23, 2020DrugsFDA
SCA Pharmaceuticals recalls Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
Hazard: Subpotency: Out-of-specification stability test result for low potency was obtained.
December 23, 2020DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only
Hazard: Failed Dissolution Specifications
December 23, 2020DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only,
Hazard: Failed Dissolution Specifications
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 23, 2020DrugsFDA
Advanced Nutriceuticals, LLC recalls CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
December 16, 2020DrugsFDA
Novocol Pharmaceutical of Canada, Inc. recalls Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL
Hazard: Labeling: Label mix-up