US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Mar 13, 2025 (1 years ago)

Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations

What was recalled

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

Recalling firm
Glenmark Pharmaceuticals Inc., USA
NDC code
16714-570-02
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0350-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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