FDAFDA · Food and drugs·Recall number D-0092-2024
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.
Published November 15, 2023 · Recall initiated: October 23, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Out of specification for dissolution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- RANOLAZINE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Nationwide
- UPC
- 0368462320600
- Lot
- Lot # 17230388, Exp. 01/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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