Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

Recall Number: D-0448-2025

Firm: Glenmark Pharmaceuticals Inc., USA

Classification: Class II

Status: Ongoing

Report Date: 20250604

Initiation Date: 20250228

Termination Date:

Reason for Recall

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Product Description

Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

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Data source: openFDA · Updated regularly