Aminocaproic Acid Injection Recalled for Particulate Matter Contamination
American Regent, Inc. is recalling Aminocaproic Acid Injection 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 particulate matter such as glass and hair in an intravenous injection poses a significant risk of serious injury, meeting the criteria for a Severe rating.
Plain-English summary
American Regent, Inc. is recalling 63,200 vials of Aminocaproic Acid Injection, USP, 250 mg/mL (5 g/20 mL). The product is packaged in 20 mL multiple dose vials for IV infusion (NDC 0517-9120-01) and 25x20 mL multiple dose vials (NDC 0517-9120-25). The affected lot number is 24299, with an expiration date of 8/31/2026. The product was 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. This is a prescription-only medication administered via intravenous infusion.
Healthcare providers and patients should stop using the affected product immediately. Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- AMINOCAPROIC ACID (AMINOCAPROIC ACID)
- Brand
- AMINOCAPROIC ACID
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 63,200
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 (2)
- Lot #: 24299
- Exp. Date: 8/31/2026.
UPCs (1)
- 0305179120253
Distribution
Distributed nationwide across the United States.
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