FDAFDA · Food and drugs·Recall number D-0794-2026
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.
Published August 26, 2026 · Recall initiated: July 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- AMINOCAPROIC ACID
- Manufacturer
- American Regent, Inc.
- Distributor
- Nationwide within the U.S
- UPC
- 0305179120253
- Lot
- Lot #: 24299, Exp. Date: 8/31/2026.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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