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.
Reported: February 12, 2025 Initiated: January 24, 2025 #D-0217-2025
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.
Reason for Recall
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- 247 blister packs
- Distribution
- FL
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by RemedyRepack Inc.. Units affected: 247 blister packs.
Why was this product recalled? ▼
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 12, 2025. Severity: Moderate. Recall number: D-0217-2025.
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