Class II Recall

SUN PHARMACEUTICAL INDUSTRIES INC

Product
Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.
Reason
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Classification
Class II
Status
Ongoing
Lot
Lot # AD94033, Exp Date: 5/31/2028.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.