FDA recall D-1535-2020

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 for recall

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.

Key facts

Status

Terminated

Initiation date

2020-08-10

Report date

2020-09-02

Termination date

2024-06-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1535-2020