Recalls / Class III
Class IIID-0049-2015
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.
- Brand name
- Carbamazepine
- Generic name
- Carbamazepine
- Active ingredient
- Carbamazepine
- Route
- Oral
- NDCs
- 51672-4005, 51672-4041, 51672-4050, 51672-4123, 51672-4124, 51672-4125, 51672-4047
- FDA application
- ANDA074649
- Affected lot / code info
- Lot 137393, exp. 10/2016
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.
Recalling firm
- Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, N/A, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 1,966 bottles
- Distribution pattern
- IL, OH, LA
Timeline
- Recall initiated
- 2014-10-21
- FDA classified
- 2014-10-27
- Posted by FDA
- 2014-11-05
- Terminated
- 2017-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0049-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.