Drug and pharmaceutical recalls
17625 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-09-20FDA-DrugAidarex Pharmaceuticals LLCClass IIIPhentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
- 2017-09-20FDA-DrugBella Pharmaceuticals, Inc.Class IIBevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA.
Lack of Assurance of Sterility.
- 2017-09-20FDA-DrugBella Pharmaceuticals, Inc.Class IIBevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Lack of Assurance of Sterility.
- 2017-09-20FDA-DrugBella Pharmaceuticals, Inc.Class IIFluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Lack of Assurance of Sterility.
- 2017-09-20FDA-DrugBella Pharmaceuticals, Inc.Class IISodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Lack of Assurance of Sterility.
- 2017-09-20FDA-DrugBella Pharmaceuticals, Inc.Class IIPhenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Lack of Assurance of Sterility.
- 2017-09-20FDA-DrugBella Pharmaceuticals, Inc.Class IILidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1(877) BELLA.
Lack of Assurance of Sterility.
- 2017-09-20FDA-DrugBella Pharmaceuticals, Inc.Class IIMIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Lack of Assurance of Sterility.
- 2017-09-20FDA-DrugBella Pharmaceuticals, Inc.Class IIL-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Lack of Assurance of Sterility.
- 2017-09-20FDA-DrugBella Pharmaceuticals, Inc.Class IIMagnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Lack of Assurance of Sterility.
- 2017-09-20FDA-DrugBella Pharmaceuticals, Inc.Class IIMethylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Lack of Assurance of Sterility.
- 2017-09-20FDA-DrugBella Pharmaceuticals, Inc.Class IIB-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1 (877) BELLA.
Lack of Assurance of Sterility.
- 2017-09-20FDA-DrugBella Pharmaceuticals, Inc.Class IICalcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Lack of Assurance of Sterility.
- 2017-09-20FDA-DrugBella Pharmaceuticals, Inc.Class IIG.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Lack of Assurance of Sterility.
- 2017-09-20FDA-DrugBella Pharmaceuticals, Inc.Class IIMannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Lack of Assurance of Sterility.
- 2017-09-20FDA-DrugBella Pharmaceuticals, Inc.Class IIMethylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Lack of Assurance of Sterility.
- 2017-09-20FDA-DrugBella Pharmaceuticals, Inc.Class IIPF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 1 (877) BELLA.
Lack of Assurance of Sterility.
- 2017-09-20FDA-DrugChiavna Saffron LLCClass ISuper Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247); and b) 6 count bottles (UPC# 601577513209), Distributed by SX Power CO., Brooklyn, NY
Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil
- 2017-09-20FDA-DrugBESTHERBS COFFEE LLCClass INew Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and each box contains 25 packets, Made in Malaysia, USA Distributor: Bestherbscoffee LLC (USA), Email: bestherbscoffee@yahoo.com
Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
- 2017-09-20FDA-DrugAndropharm, LLCClass IANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com, UPC 6 42125 50292 4
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
- 2017-09-20FDA-DrugAndropharm, LLCClass IANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydroxy-2a, 17b-dimethyl-5a-androstan-3-one azine 10 mg) capsule, packaged in 60-count bottle, Andropharm.com, UPC: 6 42125 50294 8
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
- 2017-09-20FDA-DrugCenturion Labs, LLCClass IINinjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor, Manufactured for: Centurion Labs, LLC Birmingham, AL 35243 --- NDC 23359-033-16
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
- 2017-09-20FDA-DrugCenturion Labs, LLCClass IINinjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor, Manufactured for: Centurion Labs, LLC Birmingham, AL 35243 --- NDC 23359-032-16
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
- 2017-09-20FDA-DrugVistaPharm, Inc.Class IIIHydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
- 2017-09-20FDA-DrugMEDLINE INDUSTRIES INCClass IIVitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g), Manufactured for Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-090-16
Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment.
- 2017-09-20FDA-DrugZydus Pharmaceuticals USA IncClass IIParoxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 8
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
- 2017-09-20FDA-DrugMid Valley PharmaceuticalClass IIDoctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX 78580, UPC 7 62558 00316 1.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- 2017-09-20FDA-DrugMid Valley PharmaceuticalClass IIDoctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX 78580, UPC 7 62558 00204 1.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- 2017-09-20FDA-DrugAscend Laboratories LLCClass IIIAMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10
PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
- 2017-09-13FDA-DrugImprimisRx CA, Inc., dba ImprimisRxClass IITimolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
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