FDAFDA · Food and drugs·Recall number D-0049-2015
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.
Published November 5, 2014 · Recall initiated: October 21, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CARBAMAZEPINE
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Distributor
- IL, OH, LA
- UPC
- 0351672405014
- Lot
- Lot 137393, exp. 10/2016
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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