Clear Filter
Date Brand Name Product Description Reason/ Problem Company Recall Type
09/20/2016 Wells Pharmacy Network   Sterile human and veterinary compounded products   Concern for Lack of Sterility Assurance Wells Pharmacy Network 208, 495, 183
09/14/2016 Virtus   Hyoscyamine Sulfate 0.125 mg tablets   Superpotent and subpotent test results Virtus Pharmaceuticals Opco II, LLC 208
09/08/2016 GlucaGen® HypoKit®   Glucagon [rDNA origin] for injection   Detached needles on the syringe in the kit Novo Nordisk Inc. 36, 208
09/07/2016 Family Care   Eye Wash   Microbial contamination United Exchange Corp 454, 208
09/06/2016 Rugby, Major   Eye irrigating solution and Eye wash   Possible microbial contamination United Exchange Corp. 36, 208
08/26/2016 Lamotrigine   Lamotrigine   Incorrect labeling of blister cards Impax Laboratories, Inc. 208, 36
08/19/2016 Comfort   Comfort Shield Barrier Cream Cloths   Burkholderia cepacia Sage Products 36, 208
08/18/2016 Sagent Pharmaceuticals, Inc.   Oxacillin for Injection, USP, 10 g   May contain small, dark particulate matter (iron oxide) Sagent Pharmaceuticals, Inc. 454, 208
08/18/2016 Arbor   Cetylev (acetylcysteine) effervescent tablets   Inadequate seal of the blister pack Arbor Pharmaceuticals, LLC 454, 208
08/12/2016 Comfort   Comfort Shield Barrier Cream Cloths   Burkholderia cepacia Sage Products 208, 36
08/08/2016 Multiple brands   Liquid Drug Products   Due to potential Burkholderia cepacia contamination PharmaTech, LLC 454, 208
08/05/2016 Hospira   0.25% BUPIVACAINE HYDROCHLORIDE INJECTION, USP   Due to the presence of particulate matter Hospira 208, 36
08/02/2016 Teva Pharmaceuticals   Amikacin Sulfate Injection USP   Due to potential contamination with glass particulate matter Teva Pharmaceuticals 208
08/01/2016 Comfort Shield   Barrier Cream Cloths   Due to product contamination with Burkholderia cepacia Sage Products 208, 509

The list above provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products.

Press releases issued more than 60 days ago are accessible in the Recall and Safety Alerts Archive. For more safety information in a specific product area, please visit the links below.

Recalls of raw (fresh and fresh frozen) oysters, clams, mussels, and whole and roe-on scallops See Disclaimer page regarding links to external sites
The safety of these products is ensured by the Interstate Shellfish Sanitation Conference (ISSC), which consists of federal, state, and industry partners who administer the National Shellfish Sanitation Program (NSSP).