Why it was recalled
Failed Dissolution Specifications: Out of specification for dissolution.
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.
Lot numbers, UPCs & expiration codes
Lot # 17230388, Exp. 01/31/2025
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0092-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 23, 2023
- FDA report date
- Nov 15, 2023
- Quantity
- 16,944 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0092-2024, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 93263
- Address
- 750 Corporate Dr
- Code information
- Lot # 17230388, Exp. 01/31/2025
- Postal code
- 07430-2009
- Report date
- Nov 15, 2023
- Product type
- Drugs
- Recall number
- D-0092-2024
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 16,944 bottles
- Reason for recall
- Failed Dissolution Specifications: Out of specification for dissolution.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 23, 2023
- Initial firm notification
- Letter
- Center classification date
- Nov 7, 2023