Recall: D-0092-2024

Class II - Potentially Harmful

Class IIClassification

2023-10-23Initiated

OngoingStatus

Glenmark Pharmaceuticals Inc.,Firm

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

Failed Dissolution Specifications: Out of specification for dissolution.

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.