Taro Pharmaceuticals U.S.A., Inc. recalls Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd
Recalled November 5, 2014 · FDA recall D-0049-2015 · Taro Pharmaceuticals U.S.A
Hazard
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. · FDA Class III
Units
1,966 bottles
Sold at
IL, OH, LA
Description
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.
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.
Manufacturer(s)
Taro Pharmaceuticals U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →