Drug recall D-0794-2026
Product
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.
Reason for recall
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Lots and codes
Lot #: 24299, Exp. Date: 8/31/2026.
Recall details
- Recalling firm
- American Regent, Inc., Shirley, NY
- Quantity
- 63,200 vials
- Distribution
- Nationwide within the U.S
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 24, 2026
Related products
- Aminocaproic Acid – drug information
- NDC 0517-9120 Aminocaproic Acid · Aminocaproic Acid 250 mg/mL · American Regent, Inc.