Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Nagpur, India | Makes it and packages it | Problems found, fixed voluntarilyJul 11, 2023 · 4 inspections |
Recalls
- Jun 10, 2022 · Class II · Lupin Pharmaceuticals Inc.
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Lots: Lots: M100070, M100239, Exp. 06/22, M100312, Exp.09/22, M100366, Exp.10/22
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Zileuton: every company that makes it
- Form
- tablet, extended release
- Strength
- 600 1
- Approval
- ANDA ANDA211972
- On the market since
- Aug 10, 2020
- Package NDCs
68180-169-0768180-169-1668180-169-26- Official label
- DailyMed (National Library of Medicine), updated Aug 13, 2020
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