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 |
| Delpharm Huningue | Huningue, France | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyNov 30, 2023 · 6 inspections |
| 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
- suspension, oral
- Strength
- 40 mg per 1 mL
- Approval
- NDA NDA201367
- On the market since
- Mar 3, 2011
- Package NDCs
62856-584-46- Official label
- DailyMed (National Library of Medicine), updated Dec 15, 2022
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