US Drug Recall Register
Class II · Moderate risk Terminated Initiated Oct 9, 2015 (11 years ago)

Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count…

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

Why it was recalled

Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.

What was recalled

Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01

Recalling firm
Mutual Pharmaceutical Company, Inc.
NDC code
53489-0146-01
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0572-2016

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