Data Composite

Recall D-0350-2025

US Class II Ongoing · initiated 2025-03-13

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

Product

Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India

Reason for recall

CGMP Deviations

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