Drug and pharmaceutical recalls
17707 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-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
- 2020-12-16FDA-DrugShilpa Medicare LimitedClass IIAzacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01.
CGMP Deviations
- 2020-12-16FDA-DrugShilpa Medicare LimitedClass IIAzacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726 NDC 72485-201-01.
CGMP Deviations
- 2020-12-16FDA-DrugShilpa Medicare LimitedClass IIBusulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, Vial NDC 72485-210-01, Carton NDC 72485-210-08.
CGMP Deviations
- 2020-12-16FDA-DrugFresenius Kabi USA, LLCClass IDexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05
Cross Contamination with other products: trace amounts of lidocaine
- 2020-12-16FDA-DrugAsiaticon, SA de CVClass IIProtz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med Products, Inc. Burlington, WI 53105 Made in Mexico by Asiaticon S.A. de C.V. Conkal No. 62, Mexico, Ciudad de Mexico 14200, Mexico NDC: 75192-600-02 UPC 7 503019 005002
Lack of CGMPs:
- 2020-12-16FDA-DrugAsiaticon, SA de CVClass IIV-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053 70499 3; b) 16.9 fl oz (500 ml), UPC 7 16053 70499 3; c) 33.8 fl. oz. (1000 ml) bottles: 716053704993; Manufactured by: Asiaticon S.A. de C.V. Conkar 62, Jardines del Ajusco. Tlalpan Cuidad de Mexico. 14200 ;
Lack of CGMPs:
- 2020-12-09FDA-DrugAscend Laboratories LLCClass IITizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
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