FDAHealthMarch 13, 2025

Glenmark Pharmaceuticals Inc., USA — 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

⚠️ CGMP Deviations

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: March 13, 2025

U.S. Nationwide

What's affected?

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
Brand: PRAVASTATIN SODIUM
UPC: 0316714570013
Lot code: 17221770

Additional details

Lot # 17221770, exp. date Aug-25 17221774, exp. date Aug-25 17231251, exp. date May-26 17231262, exp. date May-26 17232112, exp. date Sep-26 17232133, exp. date Sep-26

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: N/A.

View original FDA notice →

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