Key Takeaway

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, by Aurobindo Pharma USA Inc was recalled on August 10, 2020. The hazard: Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).

FDA Drug Class II Terminated

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,

Recalled: August 10, 2020 ~5748 bottles units affected D-1535-2020

Description

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.

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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,

Drugs

Company Information

Aurobindo Pharma USA Inc

Plainsboro, NJ, United States

View all 58 recalls by Aurobindo Pharma USA Inc →

Distribution

Nationwide in the U.S.

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Frequently Asked Questions

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