Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2020-12-23FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIKaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T1C1 Distributed by Kaiser Foundation Hospitals Livemore, CA 94551-9756. Made in Canada. NDC 0179-8014-30
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- 2020-12-23FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIH-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.5 oz. (14.2 g), Made with Pride & Care for H-E-B San Antonio, TX 78204 Made in Canada NDC 37808-305-01
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- 2020-12-23FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIEquate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2g), NDC 49035-812-01, b) NET WT 2 OZ (60g), NDC 49035-812-27. Distributed by: Walmart Inc., Bentonville, AR 72716.
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- 2020-12-23FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IICVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. Made in Canada NDC 59779-305-03
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- 2020-12-23FDA-DrugBASF CorporationClass IIKollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden
Cross contamination: the excipient was found to be contaminated with theophylline.
- 2020-12-23FDA-DrugBiogen MA Inc.Class IIVumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured for: Biogen Inc., Cambridge, MA 02142, NDC 64406-020-01
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
- 2020-12-23FDA-DrugSCA PharmaceuticalsClass IIIFentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
Subpotency: Out-of-specification stability test result for low potency was obtained.
- 2020-12-23FDA-DrugZydus Pharmaceuticals (USA) IncClass IILansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-772-77
Failed Dissolution Specifications
- 2020-12-23FDA-DrugZydus Pharmaceuticals (USA) IncClass IILansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77
Failed Dissolution Specifications
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IIPentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IILL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IIHIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IIGHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IITHYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IICEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IIDSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IIB12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IINANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IIGHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IIIPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IITHYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IIBPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IIAOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IIPT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IIFGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-23FDA-DrugAdvanced Nutriceuticals, LLCClass IICJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- 2020-12-16FDA-DrugNovocol Pharmaceutical of Canada, Inc.Class IIIScandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured for SEPTODONT, Inc., Louisville, CO 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, ON N1R 6X3, Canada, NDC 0362-1098-90
Labeling: Label mix-up
- 2020-12-16FDA-DrugShilpa Medicare LimitedClass IIDocetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72485-216-08.
CGMP Deviations
- 2020-12-16FDA-DrugShilpa Medicare LimitedClass IIImatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30.
CGMP Deviations
- 2020-12-16FDA-DrugShilpa Medicare LimitedClass IIImatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.
CGMP Deviations
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