Glenmark Pharmaceuticals Inc., USA recalls Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx On
Recalled April 16, 2025 · FDA recall D-0350-2025 · Glenmark Pharmaceuticals Inc., USA
Hazard
CGMP Deviations · FDA Class II
Units
N/A
Sold at
U.S. Nationwide
Description
CGMP Deviations
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
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →