Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIPotassium Chloride in 5% Dextrose in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIPhenylephrine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIDexamethasone Sodium Phosphate in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIAdenosine Injection in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IISuccinylcholine Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIKetamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIPotassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIFentanyl Citrate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IILidocaine HCl in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIMorphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIMorphine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIMidazolam HCl in 5% Dextrose in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIMidazolam HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIHYDROmorphone HCl Injection in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIEphedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIFentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIFentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIBupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIHYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugAurobindo Pharma Ltd.Class IIIMetformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05.
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
- 2018-02-21FDA-DrugThe Compounding Pharmacy of AmericaClass IHCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892
Non-Sterility
- 2018-02-21FDA-DrugAMERICAN HEALTH PACKAGINGClass IIAripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
- 2018-02-21FDA-DrugTeva Pharmaceuticals USAClass IIIFluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
- 2018-02-21FDA-DrugPharMEDium Services, LLCClass II100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
- 2018-02-21FDA-DrugPharMEDium Services, LLCClass II0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
- 2018-02-21FDA-DrugPharMEDium Services, LLCClass II15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
- 2018-02-21FDA-DrugWebrx dba RxPalace.comClass IIIBonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74
CGMP Deviations: not manufactured according to current good manufacturing practices.
- 2018-02-21FDA-DrugSun Pharmaceutical Industries, Inc.Class IIIAzelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical Ind. Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol - 389 350, Gujarat, India --- NDC 47335-779-91
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
- 2018-02-21FDA-DrugGenentech, Inc.Class IIIKlonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
- 2018-02-21FDA-DrugHetero Labs Limited Unit VClass IIFamciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
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