FDA recall D-0341-2025

Glenmark Pharmaceuticals Inc., USA · Class II · drug

Product

Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.

Reason for recall

CGMP Deviations

Distribution

U.S. Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-03-13
Report date: 2025-04-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0341-2025