FDA-Drug2023-11-15Class II
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.
Glenmark Pharmaceuticals Inc., USA
Hazard
Failed Dissolution Specifications: Out of specification for dissolution.
Sold states
Nationwide
Affected count
16,944 bottles
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0092-2024Don't want to check this manually?
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