January 2025 FDA Recall Drug by Remedyrepack Inc.
D-0217-2025 - CGMP deviations

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on January 24, 2025 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in FL and the recall is currently terminated.

Recall Number: D-0217-2025

Reason for Recall
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Initiated
01-24-2025
Reported
02-12-2025
Quantity
247 blister packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96191
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
RemedyRepack Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-17-2025
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# s: J0777493050824, Exp. 5/31/2025; J0787856062124, Exp. 7/31/2025.