Reported Nov 5, 2014 · Terminated
Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries…
Taro Pharmaceuticals U.S.A., Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Taro Pharmaceuticals U.S.A., Inc. · 3 Skyline Dr · Hawthorne, NY · 10532-2174
Is this the product you have?
- Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only
- Manufactured byTaro Pharmaceutical Industries Ltd. Haifa Bay
- Israel 26110 Distributed byTaro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4005-3
- Lot codes and dates
Lot 137393exp. 10/2016
- Amount recalled
- 1,966 bottles
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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