Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cipla Limited | Indore, India | Makes it, tests it, packages it and labels it | Serious problems, FDA actionFeb 17, 2023 · 6 inspections, 1 with FDA action |
| Cipla Limited | Pune, India | Makes the active ingredient | Problems found, fixed voluntarilyMay 8, 2024 · 7 inspections |
Recalls
- Sep 29, 2022 · Class II · Cipla
Lack of Assurance of Sterility: environmental monitoring failure.
Lots: Batch No: IA10082, IA10083, IA10084, IA10085, IA10086, exp. date 01/2023; IA10122, IA10123, IA10124, IA10125, IA10126, IA10127, IA10128, IA10129, IA10130, exp. date 02/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Arformoterol: every company that makes it
- Form
- solution, respiratory (inhalation)
- Strength
- 15 ug per 2 mL
- Approval
- ANDA ANDA207306
- On the market since
- Jun 22, 2021
- Package NDCs
69097-168-3269097-168-4869097-168-5369097-168-6469097-168-87- Official label
- DailyMed (National Library of Medicine), updated Aug 21, 2025
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