Class II
Terminated
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.
- Company
- Remedyrepack Inc.
- Recall Initiated
- January 24, 2025
- Posted
- February 12, 2025
- Recall Number
- D-0217-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 247 blister packs
- Firm Location
- Indiana, PA, United States
Reason for Recall
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Distribution
FL
Lot / Code Info
Lot #s: J0777493050824, Exp. 5/31/2025; J0787856062124, Exp. 7/31/2025.
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