American Regent, Inc.: 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
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- Company / brand
- American Regent, Inc.
- 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 / hazard
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the U.S
- Recall initiated
- 2026-07-24
- Code info
- Lot #: 24299, Exp. Date: 8/31/2026.
- Product quantity
- 63,200 vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Shirley
- State
- NY
- Country
- United States
- Event id
- 99503
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