D-0092-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- November 15, 2023
- Initiation Date
- October 23, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,944 bottles
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.
Distribution Pattern
Nationwide
Code Information
Lot # 17230388, Exp. 01/31/2025