Drug 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.
D-0049-2015
Product summary
- Event
- Event 69413
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,966 bottles
- Official record key
drug-enforcement:D-0049-2015
Official wording
Reason: 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.
Code information: Lot 137393, exp. 10/2016
Distribution pattern: IL, OH, LA
Derived failure modes
-
Unknown
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.