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Recall Observatory FDA recall evidence

Drug product

Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-198-90.

D-0325-2025

March 13, 2025

Class II

Product summary

Firm
Glenmark Pharmaceuticals Inc., USA
Event
Event 96474
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0325-2025

Official wording

Reason: CGMP Deviations

Code information: Lot # 17221771, exp. date Aug-25 17230930, exp. date Apr-26 17230931, exp. date Apr-26 17231252, exp. date May-26 17231274, exp. date May-26 17231855, exp. date Aug-26 17231916, exp. date Aug-26 17231917, exp. date Aug-26 17231945, exp. date Aug-26

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations