Class IIReported 2025-04-16

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

Recalled by Glenmark Pharmaceuticals Inc., USA

Reason for Recall

CGMP Deviations

Recall Number

D-0323-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-03-13

Reported

2025-04-16

Distribution

U.S. Nationwide

Code Info

Lot # 17231643, exp. date Jul-25 17231644, exp. date Jul-25

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.