Recall: D-0255-2022

Class III - Minor Violations

Class IIIClassification

2021-10-25Initiated

TerminatedStatus

UNICHEM PHARMACEUTICALS USA INFirm

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

Discoloration

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.