Class III
Terminated
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.
- Recall Initiated
- October 21, 2014
- Posted
- November 5, 2014
- Recall Number
- D-0049-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,966 bottles
- Firm Location
- Hawthorne, NY, United States
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.
Distribution
IL, OH, LA
Lot / Code Info
Lot 137393, exp. 10/2016
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