American Regent recalls epinephrine vials over glass, nylon particle contamination

American Regent has recalled three nationwide-distributed lots of its Epinephrine Injection, USP 30 mg/30 mL multiple-dose vials after reports of cracked and leaking containers raised sterility concerns. The company also found particulate matter, including glass, nylon, acrylic, polyethylene and cellulosic material, which could cause blood-vessel blockage, clotting, organ damage or other serious complications if injected intravenously. The affected lot numbers are 25128L1C0, 25280L1C0 and 26108L1C0. The product is used by health care professionals in hospitals and clinics for severe allergic reactions and, in some adults, dangerously low blood pressure associated with septic shock; it is not the EpiPen auto-injector used by consumers. Hospitals, clinics, pharmacies and other facilities should stop using the recalled vials, separate and return them through American Regent’s recall process, and contact a health care provider with questions; no related adverse events had been reported as of Sept. 3.