Drug recall D-0049-2015
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.
Reason for recall
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.
Lots and codes
Lot 137393, exp. 10/2016
Recall details
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY
- Quantity
- 1,966 bottles
- Distribution
- IL, OH, LA
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 21, 2014
- Terminated
- April 3, 2017
Related products
- NDC 51672-4005 Carbamazepine · Carbamazepine 200 mg/1 · Sun Pharmaceutical Industries, Inc.