Pravastatin Sodium Tablets recalled over manufacturing violations

Recall date

March 13, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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 O…

Recall number

D-0350-2025

FDA classification

Class II

Brand / firm

Glenmark Pharmaceuticals Inc., USA

Sold / distributed

U.S. Nationwide

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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