Recall D-0340-2025

US Class II Ongoing · initiated 2025-03-13

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

Product

Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-433-18

Reason for recall

CGMP Deviations

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