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.
Recall initiated: 20141021
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated