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.
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.
Lot numbers, UPCs & expiration codes
Lot 137393, exp. 10/2016
Where it was sold
IL, OH, LA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0049-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 21, 2014
- FDA report date
- Nov 5, 2014
- Quantity
- 1,966 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-0049-2015, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 69413
- Address
- 3 Skyline Dr
- Code information
- Lot 137393, exp. 10/2016
- Postal code
- 10532-2174
- Report date
- Nov 5, 2014
- Product type
- Drugs
- Recall number
- D-0049-2015
- Classification
- Class III
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 1,966 bottles
- Termination date
- Apr 3, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- IL, OH, LA
- Recall initiation date
- Oct 21, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 27, 2014