FDA recall D-0217-2025

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.

Distribution

FL

Key facts

Status

Terminated

Initiation date

2025-01-24

Report date

2025-02-12

Termination date

2025-07-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0217-2025