Recall D-0341-2025

US Class II Ongoing · initiated 2025-03-13

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

Product

Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.

Reason for recall

CGMP Deviations

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