October 2021 FDA Recall Topiramate by Unichem Pharmaceuticals Usa Inc
D-0255-2022 - Discoloration
This Class III drug recall was voluntarily initiated by Unichem Pharmaceuticals Usa Inc on October 25, 2021 for the product Topiramate. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0255-2022
Discoloration
10-25-2021
12-01-2021
1284 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
UNICHEM PHARMACEUTICALS USA INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
10-12-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : ZTPM20044, Exp. Date 09/30/2022
