American Regent, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967.
Lot #: 24299, Exp. Date: 8/31/2026.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →