FDA Announces Nationwide Recall of Epinephrine Injections Due to Particulate Matter and Sterility Concerns

The U.S. Food and Drug Administration (FDA) 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 by American Regent was initiated after customer complaints of leaking and cracked vials, leading to a lack of sterility assurance. An investigation also revealed the presence of particulate matter, including nylon, cellulosic, acrylic, polyethylene, and glass, in the product. These injections are used for emergency treatment of severe allergic reactions and to increase blood pressure in adult patients with septic shock.