Glenmark Pharmaceuticals Inc., USA recalls Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Lim
Recalled November 15, 2023 · FDA recall D-0092-2024 · Glenmark Pharmaceuticals Inc., USA
Hazard
Failed Dissolution Specifications: Out of specification for dissolution. · FDA Class II
Units
16,944 bottles
Sold at
Nationwide
Description
Failed Dissolution Specifications: Out of specification for dissolution.
Product
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.
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →