September 2014 FDA Recall Topiramate by Zydus Pharmaceuticals Usa Inc
D-0015-2015 - Presence of Foreign Tablets
This Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals Usa Inc on September 15, 2014 for the product Topiramate. The FDA reported the reason for recall as presence of foreign tablets. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0015-2015
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
09-15-2014
10-22-2014
14,568 Bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Zydus 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
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
09-20-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.
Batch or Lot Expiration Information
Lot# : MN9828, Expiry: Oct 2015.
