Recall: D-1535-2020

Class II - Potentially Harmful

Class IIClassification

2020-08-10Initiated

TerminatedStatus

Aurobindo Pharma USA Inc.Firm

Product

Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC: 65862-420-05.

Reason

Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).

Distribution

Nationwide in the U.S.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.