Glenmark Pharmaceuticals Inc., USA recalls Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-1
Recalled July 24, 2024 · FDA recall D-0612-2024 · Glenmark Pharmaceuticals Inc., USA
Hazard
Failed Dissolution Specifications: results below specifications · FDA Class II
Units
a) 145,800 bottles; b) 1,368 bottles
Sold at
USA Nationwide
Description
Failed Dissolution Specifications: results below specifications
Product
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →