Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and label...
FDA Recall #D-1450-2014 — Class II — September 27, 2011
Product Description
Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Amneal/Interpharm, NDC 53746-272-01
Reason for Recall
Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg
Recalling Firm
Shamrock Medical Solutions Group LLC — Lewis Center, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
284/800 mg tablets
Distribution
Product was shipped to the following states: CO, MA, OH, TX & WY.
Code Information
Lot 00288N, Use By: 9/15/2012, NDC 53746-272-01
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated