HEALINE

Drug Recalls

Source: U.S. Food and Drug Administration

Updated: May 28, 2019

Date Brand Name Product Description Reason/ Problem Company Recall Type
05/11/2019 Promacta Promacta 12.5 mg oral suspension Potential Foreign Material Novartis
05/03/2019 Heritage Losartan Potassium Tablets USP Defect Vivimed
05/01/2019 Par Pharmaceutical Mycophenolate Mofetil for injection Potential Foreign Material Par Pharmaceutical, Inc.
04/30/2019 Sagent Pharmaceuticals Ketorolac Tromethamine Injection Potential Lack of Sterility Sagent Pharmaceuticals
04/29/2019 AmEx Pharmacy Bevacizumab 1.25mg/0.05mL 31G Injectable Device & Drug Safety AmEx Pharmacy
04/26/2019 GSMS Incorporated Losartan Potassium 25 mg and 100 mg Tablets USP Device & Drug Safety Teva Pharmaceuticals USA, Inc
04/24/2019 Legacy   Losartan Potassium USP   Impurity found Legacy Pharmaceutical Packaging 454, 208
04/19/2019 Alvogen   Fentanyl Transdermal System   Mislabeled Alvogen, Inc 454, 208
04/18/2019 Torrent Pharmaceuticals Limited   Losartan potassium tablets, USP; Losartan potassium and Hydrochlorothiazide tablets, USP   due to the detection of trace amounts of N-nitrosodiethylamine (NDEA) Torrent Pharmaceuticals Limited 208
03/25/2019 Legacy   Losartan Potassium USP   Impurity found Legacy Pharmaceutical Packaging 208
03/22/2019 Leopard   Dietary Supplement   Undeclared sildenafil USA LESS 454, 208
03/21/2019 BLUE FUSION   Capsules marketed as a dietary supplement for male enhancement   Tainted with sildenafil, tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin and daidzein Ata Int. Inc. 208
03/18/2019 Mylan   Levoleucovorin Injection, 250 mg/25 mL   Due to the presence of particulate matter identified as copper salts Mylan Institutional LLC 454, 208
03/15/2019 Legacy   Losartan Potassium USP   Impurity found Legacy Pharmaceutical Packaging 208
03/15/2019 Hospira   Sodium bicarbonate injection USP   Particulate matter Hospira, Inc. 454, 208
03/05/2019 Life-Line tm   Additive for human drinking water   Potentially contaminated with Pseudomonas aeruginosa McDaniel Life-Line LLC 208
03/04/2019 Apotex Corp.   Drospirenone and Ethinyl Estradiol Tablets, USP   May Contain Defective Blisters Apotex Corp. 208
03/01/2019 Sunstone Organics   White Vein Kratom and Maeng Da Kratom   Potential for Salmonella Sunstone Organics 208
03/01/2019 Torrent Pharma   Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide Tablets USP   Contains N-Methylnitrosobutyric acid (NMBA) Torrent Pharmaceuticals Limited 454, 208
03/01/2019 Aurobindo, Acetris   Valsartan and Amlodipine and Valsartan tablets   Contains N-nitrosodiethylamine (NDEA), AurobindoPharma USA, Inc. 208
02/28/2019 Camber Pharmaceuticals, Inc.   Losartan Tablets USP 25 mg, 50 mg, and 100 mg   Contains N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Camber Pharmaceuticals, Inc. 208
02/25/2019 ChemoLock and ChemoClave   Vial Spikes   Due to the Potential for Burr Particulate ICU Medical, Inc. 208
02/22/2019 Macleods   Losartan Potassium/Hydrochlorothiazide Combination Tablets   Impurity N-nitroso-diethylamine (NDEA) Macleods Pharmaceuticals Limited 208
02/08/2019 McDaniel Life-Line   Indian Herb (topical)   marketed without an approved NDA/ANDA McDaniel Life-Line LLC 208
02/04/2019 Dr. Reddy's Laboratories Ltd.   Infusion Bags (Levetiracetram in 0.54% Sodium Chloride Injection)   Mislabeling Dr. Reddy's Laboratories Ltd. 208, 91
01/29/2019 CVS, Equate   Oral ibuprofen   Higher levels of ibuprofen concentration Tris Pharma, Inc. 208
01/22/2019 Torrent Pharmaceuticals Limited   "losartan potassium tablets, USP; losartan potassium hydrochlorothiazide combination tablets, USP"   due to the detection of trace amounts of N-nitrosodiethylamine (NDEA) Torrent Pharmaceuticals Limited 208
01/18/2019 Prinston Pharmaceutical Inc. dba Solco Healthcare LLC   Irbesartan and Irbesartan HCTZ Tablets   Detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) Prinston Pharmaceutical Inc. dba Solco Healthcare LLC 208
01/08/2019 Rhino   Rhino 5K capsules   Unapproved new drug Happy Together, Inc. 208, 202, 512, 54
01/08/2019 Sun Pharma   Vecuronium Bromide for Injection   Particulate matter Sun Pharmaceutical Industries, Inc. 208
01/05/2019 Lupin Pharmaceuticals, Inc.   Ceftriaxone for Injection, USP   Due to products contain visual grey particulate matter in reconstituted vial Lupin Pharmaceuticals, Inc. 454, 208
01/03/2019 Torrent Pharmaceuticals Limited   Losartan potassium tablets, USP   due to the detection of trace amounts of N-nitrosodiethylamine (NDEA) Torrent Pharmaceuticals Limited 208

 

Copyright © 2019 HealthDay. All rights reserved.