Nationwide Recall Issued for Epinephrine Injections 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 was prompted by customer complaints of leaking and cracked vials, and an investigation revealed the presence of particulate matter, including nylon, cellulosic, acrylic, polyethylene, and glass, raising concerns about sterility. This recall affects vials used in hospitals and clinics, not EpiPen auto-injectors.