Home / Recalls / Glenmark Pharmaceuticals Inc., USA / D-0323-2025

D-0323-2025 Class II Ongoing

Recalled by Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

Recall Details

Product Type: Drugs
Report Date: April 16, 2025
Initiation Date: March 13, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Product Description

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

Distribution Pattern

U.S. Nationwide

Code Information

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

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