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FDARecalled Apr 16, 2025 · #D-0350-2025

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 Pharmaceut...

Hazard

Class II — temporary health risk

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Description

CGMP Deviations Classification: Class II Distribution: U.S. Nationwide

Product details

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
Type
Drugs
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Model numbers
17221770
UPCs