Recalling firm
RemedyRepack Inc.
Product type
Drug
Status
Terminated
Report date
2025-02-12
Distribution
FL
Firm state
PA
Product quantity
247 blister packs
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Product description
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.
Code / lot info
Lot #s: J0777493050824, Exp. 5/31/2025; J0787856062124, Exp. 7/31/2025.
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.