NDC 55154-5730
Acetylcysteine 100 mg per 1 mL inhalant
On the label: Cardinal Health 107, LLC. It's repackaged: Cardinal Health 107, LLC rebottles it from American Regent, Inc.'s NDC 0517-7504.
Where the pills inside were 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
- 100 mg per 1 mL
- Approval
- ANDA ANDA072489
- On the market since
- May 6, 2011
- Package NDCs
55154-5730-5- Official label
- DailyMed (National Library of Medicine), updated Apr 7, 2026
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