Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| InvaGen Pharmaceuticals, Inc | Hauppauge, NY, United States | Makes it and tests it | No problems foundOct 25, 2023 · 18 inspections |
| InvaGen Pharmaceuticals, Inc | Central Islip, NY, United States | Packages it | Problems found, fixed voluntarilyJul 17, 2026 · 4 inspections |
Recalls
- Nov 17, 2023 · Class I · InvaGen Pharmaceuticals, Inc.
Defective Container: powder may leak out of the pouch
Lots: Lot #: NB301030, Exp. Date 03/31/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Vigabatrin: every company that makes it
- Form
- powder, for solution, oral
- Strength
- 500 mg per 1 mL
- Approval
- ANDA ANDA211592
- On the market since
- Dec 4, 2019
- Package NDCs
69097-964-53- Official label
- DailyMed (National Library of Medicine), updated May 10, 2022
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