American Regent, Inc. Recalls Epinephrine Injection Due to Leaking Vials and Particulate Matter

American Regent, Inc. has issued a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/30 mL multi-dose vials. The recall is due to customer complaints of leaking and cracked vials, which raise concerns about sterility, and the presence of particulate matter including 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. While no adverse events have been reported to date, the recall is a critical patient safety measure for this emergency treatment for allergic reactions and septic shock-associated hypotension.