Recall D-0315-2025

US Class II Ongoing · initiated 2025-03-13

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

Product

Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-408-60

Reason for recall

CGMP Deviations

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