PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 27, 2016 Initiated: October 9, 2015 #D-0572-2016

Product Description

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

Reason for Recall

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

Details

Units Affected
9526
Distribution
MS
Location
Philadelphia, PA

Frequently Asked Questions

What product 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. Recalled by Mutual Pharmaceutical Company, Inc.. Units affected: 9526.
Why was this product recalled?
Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 27, 2016. Severity: Moderate. Recall number: D-0572-2016.