Product: Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-713-08
Reason for recall: CGMP Deviations
Recall initiated: 20250313
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated