FDA-Drug2025-06-18Class III
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90
Glenmark Pharmaceuticals Inc., USA
Hazard
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Sold states
Nationwide USA and PR
Affected count
6,759 Con - 90 bottle pack
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0462-2025Don't want to check this manually?
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