Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Glenmark Pharmaceuticals Inc., USA

NDC code

68462-198-90

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0325-2025

Other Pravastatin recalls

See all

Class II · Moderate risk Ongoing Mar 13, 2025

Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd…

Reason CGMP Deviations

Glenmark Pharmaceuticals Inc., USA NDC 16714-570-02 D-0350-2025

Class II · Moderate risk Ongoing Mar 13, 2025

Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by…

Reason CGMP Deviations

Glenmark Pharmaceuticals Inc., USA NDC 16714-559-01 D-0349-2025

Class II · Moderate risk Ongoing Mar 13, 2025

Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only…

Reason CGMP Deviations

Glenmark Pharmaceuticals Inc., USA NDC 68462-196-05 D-0341-2025

Class II · Moderate risk Ongoing Jun 28, 2024

Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx…

Reason Failed Dissolution Specifications: results below specifications

Glenmark Pharmaceuticals Inc., USA NDC 68462-198-90 D-0612-2024

Class II · Moderate risk Ongoing Mar 23, 2023

Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-8215-9 D-0521-2023