The Recall Desk
ModerateFDA (Drugs)·D-0572-2016·Announced 2016-01-27

Mutual Pharmaceutical Recalls Sulfamethoxazole and Trimethoprim Tablets Due to Foreign Substance

Mutual Pharmaceutical Company is recalling specific lots of Sulfamethoxazole and Trimethoprim tablets due to the presence of a polyethylene piece.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a foreign substance (polyethylene piece) without reported injuries or illnesses in the source text.

Plain-English summary

Mutual Pharmaceutical Company, Inc. is recalling 9,526 bottles of Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count. The recall is limited to Lot # 6727001 with an expiration date of 01/18. The product is distributed by Sun Pharmaceutical Industries, Inc.

The recall was initiated because a polyethylene piece was found on the finished product. This is classified as an FDA Class II recall. The distribution pattern is listed as MS.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for instructions on how to return the medication or obtain a replacement.

The recalled product

Product
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
Affected units
9,526

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot # 6727001 Exp 01/18

Distribution

Distributed in 1 state: