FDAFDA · Food and drugs·Recall number D-0323-2025
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
Published April 16, 2025 · Recall initiated: March 13, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- RUFINAMIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- U.S. Nationwide
- UPC
- 0368462714089
- Lot
- Lot # 17231643, exp. date Jul-25 17231644, exp. date Jul-25
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.