Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| American Regent, Inc. | Shirley, NY, United States | Makes it and tests it | Problems found, fixed voluntarilyApr 24, 2024 · 12 inspections, 1 with FDA action |
Recalls
- Jul 24, 2026 · Class II · American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Lots: Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027 - Jul 24, 2026 · Class II · American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Lots: Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Acetylcysteine: every company that makes it
- Form
- inhalant, respiratory (inhalation)
- Strength
- 200 mg per 1 mL
- Approval
- ANDA ANDA072547
- On the market since
- Oct 1, 1995
- Package NDCs
0517-7604-25- Official label
- DailyMed (National Library of Medicine), updated Dec 17, 2024
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?