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

American Regent, Inc. has initiated 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, leading to a lack of assurance of sterility, and the presence of particulate matter identified as Nylon, Cellulosic, Acrylic, Polyethylene, and Glass. Intravenous administration of products containing particulate matter can cause serious adverse health consequences, including blood clots, organ damage, and death.