Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Ajinomoto Omnichem | Balen, Belgium | Makes the active ingredient | Problems found, fixed voluntarilyJun 24, 2025 · 5 inspections |
| Bushu Pharmaceuticals, Ltd. | Kodama-gun, Japan | Makes it, tests it and packages it | No problems foundNov 10, 2023 · 3 inspections |
| Pace Analytical Life Sciences, LLC | Morrisville, NC, United States | Tests it | No problems foundJul 10, 2026 · 1 inspection |
| Pharma Packaging Solutions, LLC | Clinton, TN, United States | Packages it | No problems foundJun 28, 2023 · 4 inspections |
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: 80643
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Rufinamide: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 400 mg
- Approval
- NDA NDA021911
- On the market since
- Nov 14, 2008
- Package NDCs
62856-583-1462856-583-52- Official label
- DailyMed (National Library of Medicine), updated Dec 15, 2022
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?