Class II
Ongoing
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.
This recall is currently active, issued November 15, 2023. It was issued by Glenmark Pharmaceuticals Inc., Usa.
- Recall Initiated
- October 23, 2023
- Posted
- November 15, 2023
- Recall Number
- D-0092-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 16,944 bottles
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: Out of specification for dissolution.
Distribution
Nationwide
Lot / Code Info
Lot # 17230388, Exp. 01/31/2025
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