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.
Reported: November 5, 2014 Initiated: October 21, 2014 #D-0049-2015
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Units Affected
- 1,966 bottles
- Distribution
- IL, OH, LA
- Location
- Hawthorne, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Taro Pharmaceuticals U.S.A., Inc.. Units affected: 1,966 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 5, 2014. Severity: Low. Recall number: D-0049-2015.
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