Recalls / Class II
Class IID-0092-2024
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.
- Brand name
- Ranolazine
- Generic name
- Ranolazine
- Active ingredient
- Ranolazine
- Route
- Oral
- NDCs
- 68462-319, 68462-320
- FDA application
- ANDA211082
- Affected lot / code info
- Lot # 17230388, Exp. 01/31/2025
Why it was recalled
Failed Dissolution Specifications: Out of specification for dissolution.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 16,944 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-10-23
- FDA classified
- 2023-11-07
- Posted by FDA
- 2023-11-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0092-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.