FDA recall D-0255-2022

Product

Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05.

Reason for recall

Discoloration

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2021-10-25

Report date

2021-12-01

Termination date

2022-10-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0255-2022