Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Tirupati, India | Makes it and tests it | Problems found, fixed voluntarilyDec 17, 2025 · 5 inspections |
Recalls
- Jul 21, 2023 · Class II · Aurobindo Pharma USA Inc.
cGMP deviations: Batch was released prior to approval.
Lots: Lot #: RB2023001A, Exp 02/2025 - Jul 21, 2023 · Class II · Aurobindo Pharma USA Inc.
cGMP deviations: Batch was released prior to approval.
Lots: Lot #: RB4023002A, Exp 02/2025
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
- ANDA ANDA217230
- On the market since
- Jun 16, 2023
- Package NDCs
59651-617-08- Official label
- DailyMed (National Library of Medicine), updated Jul 19, 2025
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?