Skip to content
Recall Observatory FDA recall evidence

Drug 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.

D-1535-2020

August 10, 2020

Class II

Product summary

Firm
Aurobindo Pharma USA Inc.
Event
Event 86190
Status
Terminated
Classification
Class II
Quantity
5748 bottles
Official record key
drug-enforcement:D-1535-2020

Official wording

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

Code information: Lot #s: STSD19109-A, Exp. 05/31/2022; SP1D19083AA3, SP1D19084AA3, Exp. 08/31/2022.

Distribution pattern: Nationwide in the U.S.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance