American Regent, Inc.: Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneou
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The text below is copied from the official FDA (press release) record. If anything differs, the official notice is correct.
- Company / brand
- American Regent, Inc.
- Product
- Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01
- Reason / hazard
- Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the U.S.A
- Recall initiated
- 2026-08-11
- Product type
- Food & Beverages,
- Code info
- Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027
- Product quantity
- 31,935 30mL-vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Shirley
- State
- NY
- Country
- United States
- Event id
- 99670
- Enforcement url
- https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99670
- Enforcement id
- fda-drug-D-0865-2026
- Announced product
- Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial
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