FDA-Drug2014-11-05Class III
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.
Taro Pharmaceuticals U.S.A., Inc.
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.
Sold states
IL, OH, LA
Affected count
1,966 bottles
Manufactured in
3 Skyline Dr, N/A, Hawthorne, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0049-2015Don't want to check this manually?
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