American Regent Recalls Acetylcysteine Solution Due to Particulate Matter
American Regent, Inc. is recalling specific lots of Acetylcysteine Solution, USP, 10% due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. The presence of glass and paraformaldehyde particulate matter in a respiratory medication presents a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
American Regent, Inc. is recalling Acetylcysteine Solution, USP, 10% (100 mg/mL), packaged in 4 mL vials and 25x4 mL vials. The product is labeled "NOT FOR INJECTION" and is intended for respiratory (inhalation) use. The recall involves 316,450 vials distributed nationwide within the U.S.
The recall was initiated because the product was found to be contaminated with particulate matter. The specific contaminants identified include hair, glass, and/or paraformaldehyde. The affected lots are 24418 (Exp. 11/30/2026), 25131 (Exp. 3/31/2027), and 25349 (Exp. 8/31/2027).
Healthcare providers and patients should check their inventory for the specific NDCs and lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the distributor or manufacturer per the recall instructions. This is a Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ACETYLCYSTEINE (ACETYLCYSTEINE)
- Brand
- ACETYLCYSTEINE
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Respiratory Medication
- Affected units
- 316,450
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: 24418
- Exp. Date: 11/30/2026
- 25131
- Exp. Date: 3/31/2027
- 25349
- Exp. Date: 8/31/2027
UPCs (4)
- 0305177510032
- 0305177604250
- 0305177504253
- 0305177610039
Distribution
Distributed nationwide across the United States.
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