Drug 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.
D-0092-2024
Product summary
- Event
- Event 93263
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16,944 bottles
- Official record key
drug-enforcement:D-0092-2024
Official wording
Reason: Failed Dissolution Specifications: Out of specification for dissolution.
Code information: Lot # 17230388, Exp. 01/31/2025
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification