Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intersect ENT, Inc. | Menlo Park, CA, United States | Makes it | No problems foundAug 7, 2025 · 4 inspections |
Recalls
- Jan 4, 2023 · Class III · Intersect ENT, Inc.
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Lots: Lot #s: 10111003, Exp 12/31/2022; 10203002, Exp 01/31/2023; 10302002, 10325001, Exp 02/28/2023; 10519001, 10526002, Exp 04/30/2023; 10602002, Exp 05/31/2023; 10819004, Exp 09/30/2023; 21092101, 21111901, Exp 10/31/2023; 21110402, Exp 12/31/2023.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Mometasone: every company that makes it
- Form
- implant, intrasinal
- Strength
- 1350 ug
- Approval
- NDA NDA209310
- On the market since
- Feb 1, 2018
- Package NDCs
10599-003-01- Official label
- DailyMed (National Library of Medicine), updated Jan 26, 2023
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