US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 27, 2011 (15 years ago)

Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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

Recalling firm
Shamrock Medical Solutions Group LLC
NDC code
53746-272-01
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1450-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Sulfamethoxazole recalls

See all