American Regent Recalls Acetylcysteine Solution Due to Particulate Matter
American Regent, Inc. is recalling Acetylcysteine Solution USP due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of glass and paraformaldehyde particulate matter in a respiratory medication poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
American Regent, Inc. is recalling Acetylcysteine Solution, USP, 20% (200 mg/mL), packaged in 4 mL and 25x4 mL vials. The product is labeled "NOT FOR INJECTION" and is a prescription-only medication used for respiratory purposes. The recall involves 169,200 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 24426 (Expiration Date: 11/30/2026) and 25220 (Expiration Date: 5/31/2027).
Healthcare providers and patients should check their inventory for the specific NDCs and lot numbers listed in the recall notice. The product should not be used until further notice. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- ACETYLCYSTEINE (ACETYLCYSTEINE)
- Brand
- ACETYLCYSTEINE
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 169,200
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 (4)
- Lot #: 24426
- Exp. Date: 11/30/2026
- 25220
- Exp. Date: 5/31/2027.
UPCs (4)
- 0305177510032
- 0305177604250
- 0305177504253
- 0305177610039
Distribution
Distributed nationwide across the United States.
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