United StatesEpinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multiple-dose 30 mL vials (NDC 0517-3030-01) from American Regent, Inc., lots 25128L1C0 (exp 8/31/2026), 25280L1C0 (exp 10/31/2026), and 26108L1C0 (exp 7/31/2027), sold nationwide in the U.S., is affected. It was recalled because particulate matter (nylon, cellulosic, acrylic, polyethylene, and glass) and broken and leaking vials were identified, creating a lack of assurance of sterility.
What's being recalled
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
Recalling firm: American Regent, Inc., Shirley, NY, United States.
How to identify it
Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the U.S.A
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)