Class IIReported 2025-04-16

Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-198-90.

Recalled by Glenmark Pharmaceuticals Inc., USA

Reason for Recall

CGMP Deviations

Recall Number

D-0325-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-03-13

Reported

2025-04-16

Distribution

U.S. Nationwide

Code Info

Lot # 17221771, exp. date Aug-25 17230930, exp. date Apr-26 17230931, exp. date Apr-26 17231252, exp. date May-26 17231274, exp. date May-26 17231855, exp. date Aug-26 17231916, exp. date Aug-26 17231917, exp. date Aug-26 17231945, exp. date Aug-26

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.