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 Pharmaceu

FDA recall notice · announced November 15, 2023 · Glenmark Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

Failed Dissolution Specifications: Out of specification for dissolution.

Notes

Distribution: Nationwide
Lot/code information: Lot # 17230388, Exp. 01/31/2025
Quantity: 16,944 bottles
Status: Ongoing
Products in this recall event:
- 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 Prades (D-0092-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.