UNICHEM PHARMACEUTICALS USA INC: Drug Recall

Recall #D-0255-2022 · 10/25/2021

Class III: Low Risk

Recall Details

Recall Number: D-0255-2022
Classification: Class III
Product Type: Drug
Recalling Firm: UNICHEM PHARMACEUTICALS USA INC
Status: Terminated
Date Initiated: 10/25/2021
Location: East Brunswick, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1284 bottles

Reason for Recall

Discoloration

Product Description

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.

Distribution Pattern

Nationwide within the United States

Other Recalls by UNICHEM PHARMACEUTICALS USA INC

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Class III: Low Risk 09/19/2022

Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,

View all recalls by UNICHEM PHARMACEUTICALS USA INC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.