American Regent initiated a nationwide recall of three lots of its epinephrine injections, USP 30 mg/30 mL, citing sterility concerns and the discovery of particulate matter including nylon, cellulosic, acrylic, polyethylene and glass.
The recall followed customer complaints about leaking and cracked vials. American Regent's internal investigation confirmed the presence of particulate matter within the injections.
Epinephrine injections are used to treat severe allergic reactions and to increase blood pressure in patients requiring immediate medical intervention. The U.S. Food and Drug Administration warned that intravenous administration of medication containing particulate matter can lead to life-threatening blood clots, permanent organ damage or death. Cracked vials also jeopardize the medication's sterility, potentially contaminating the drug.
American Regent is notifying distributors and customers about the recall by mail. Consumers, retailers and healthcare facilities must stop using the recalled product immediately and either discard the injections or return them to American Regent.
The company said it has not received any adverse event reports directly related to the recall. For questions, individuals can contact American Regent at 1-800-645-1706, available Monday through Friday during standard business hours.
