Recall D-0217-2025

US Class II Terminated · initiated 2025-01-24

Recalling firm

RemedyRepack Inc., PA

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 for recall

CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.

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