FDA recall D-0719-2021

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 for recall

Presence of Foreign Substance- Potential of metal contamination.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2021-07-07

Report date

2021-08-18

Termination date

2023-10-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0719-2021