Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Reported: June 4, 2025 Initiated: February 28, 2025 #D-0449-2025
Product Description
Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Reason for Recall
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- [100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 bottles
- Distribution
- U.S. Nationwide
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: [100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 bottles.
Why was this product recalled? ▼
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 4, 2025. Severity: Moderate. Recall number: D-0449-2025.
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