drugs Class III Updated 2014-11-05

Taro Pharmaceuticals U.S.A., Inc. recalls Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle,

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Affected States: IL, OH, LA
Lot/Code Info: Lot 137393, exp. 10/2016
View official government recall

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