Recall: D-0719-2021

Class II - Potentially Harmful

Class IIClassification

2021-07-07Initiated

TerminatedStatus

Aurobindo Pharma USA Inc.Firm

Product

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

Reason

Presence of Foreign Substance- Potential of metal contamination.

Distribution

Nationwide

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