MedicineWatch US
Class II Recall

RemedyRepack Inc.

Product
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
Reason
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Classification
Class II
Status
Terminated
Lot
Lot #s: J0777493050824, Exp. 5/31/2025; J0787856062124, Exp. 7/31/2025.
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.
RemedyRepack Inc. — Class II Recall | MedicineWatch US