American Regent, Inc. Issues Nationwide Recall of Epinephrine Injection Due to Particulate Matter and Sterility Concerns

The U.S. Food and Drug Administration (FDA) announced that American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi-dose vials. The recall is due to customer complaints of leaking and cracked vials, which compromises sterility, and the presence of particulate matter identified as Nylon, Cellulosic, Acrylic, Polyethylene, and Glass. Intravenous administration of epinephrine containing particulate matter can lead to serious adverse health consequences, including blood vessel blockage, pulmonary embolism, organ damage, and death. Cracked vials also pose a risk of contamination.