Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenm...
FDA Recall #D-0092-2024 — Class II — October 23, 2023
Product Description
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.
Reason for Recall
Failed Dissolution Specifications: Out of specification for dissolution.
Recalling Firm
Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
16,944 bottles
Distribution
Nationwide
Code Information
Lot # 17230388, Exp. 01/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated