Class II · Moderate risk Ongoing
Amlodipine and Olmesartan Medoxomil Tablets
Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Carbamazepine Tablets USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
What 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.
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- NDC code
- 51672-4005-3
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0049-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Pine recalls
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Class II · Moderate risk Ongoing
Cleviprex
Reason Lack of Assurance of Sterility
Class III · Low risk Ongoing
Epinephrine Injection
Reason Failed Impurities/Degradations Specifications
Class II · Moderate risk Ongoing
Amlodipine and Olmesartan Medoxomil Tablets
Reason Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Class II · Moderate risk Ongoing
EPINEPHRINE Injection
Reason Lack of Assurance of Sterility
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