Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Mission Pharmacal Company | Boerne, TX, United States | Makes it | Problems found, fixed voluntarilySep 22, 2022 · 8 inspections, 1 with FDA action |
Recalls
- Sep 30, 2022 · Class II · Ingenus Pharmaceuticals Llc
Out of specification for related substances (impurities).
Lots: Lot #: 22E040 Exp. 07/2023; 22F038 Exp. 08/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Flunisolide: every company that makes it
- Form
- solution, nasal
- Strength
- 0.25 mg per 1 mL
- Approval
- ANDA ANDA207802
- On the market since
- Jun 23, 2022
- Package NDCs
50742-317-25- Official label
- DailyMed (National Library of Medicine), updated Apr 30, 2025
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