Three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL), have been recalled after complaints of leaking and cracked vials prompted an investigation that identified particulate matter, including glass. The affected product is supplied in multidose vials, allowing the person administering epinephrine to draw the required amount for a patient experiencing an allergic reaction. The investigation identified particulate matter including nylon, cellulosic, acrylic, polyethylene, and glass.

According to the FDA recall notice, particulate matter can cause vascular blockage and clotting, potentially cutting off blood flow to vital organs and leading to a life-threatening pulmonary embolism, permanent organ damage, or death. The particles may also cause local vein irritation, inflammatory reactions, aggravation of preexisting infections, and allergic reactions. Cracked vials can compromise…