Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.
Reported: February 12, 2025 Initiated: January 22, 2025 #D-0215-2025
Product Description
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.
Reason for Recall
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Distribution
- Nationwide in the U.S
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.. Recalled by Glenmark Pharmaceuticals Inc., USA.
Why was this product recalled? ▼
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 12, 2025. Severity: Moderate. Recall number: D-0215-2025.
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