FDA Announces Nationwide Recall of Epinephrine Injections Due to Cracked Vials and Sterility Concerns

American Regent has issued a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi-dose vials. The recall was prompted by customer complaints of leaking and cracked vials, which raise concerns about sterility. An investigation also revealed the presence of particulate matter, including nylon, cellulosic, acrylic, polyethylene, and glass. Intravenous administration of products containing particulate matter can lead to serious adverse health consequences. The affected products were distributed nationwide in the United States.