FDA-Drug2025-02-12Class II
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.
RemedyRepack Inc.
Hazard
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Sold states
FL
Affected count
247 blister packs
Manufactured in
625 Kolter Dr Ste 4, Indiana, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0217-2025Don't want to check this manually?
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