October 2014 FDA Recall Carbamazepine by Taro Pharmaceuticals U.s.a., Inc.
D-0049-2015 - Marketed without an Approved NDA/ANDA
This Class III drug recall was voluntarily initiated by Taro Pharmaceuticals U.s.a., Inc. on October 21, 2014 for the product Carbamazepine. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in IL, OH, LA and the recall is currently terminated.
Recall Number: D-0049-2015
Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.
10-21-2014
11-05-2014
1,966 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.
Taro Pharmaceuticals U.S.A., 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.
IL, OH, LA
04-03-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4005-3.
Batch or Lot Expiration Information
Lot# Lot 137393, exp. 10/2016
