FDA-Drug2024-07-24Class II
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,
Glenmark Pharmaceuticals Inc., USA
Hazard
Failed Dissolution Specifications: results below specifications
Sold states
USA Nationwide
Affected count
a) 145,800 bottles; b) 1,368 bottles
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
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,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0612-2024Don't want to check this manually?
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