Epinephrine injection recalled over potentially fatal health risks
Consumers, retailers and health care facilities should stop using the product and discard or return it, the FDA said.
( NewsNation ) — A pharmaceutical company is voluntarily recalling three lots of epinephrine injections, USP 30 mg/30 mL, over sterility concerns and the potential presence of particulate matter.
American Regent initiated the nationwide recall after customers complained about “leaking and cracked vials,” according to a company notice posted by the U.S. Food and Drug Administration . “The firm’s investigation also revealed the presence of particulate matter identified as Nylon, Cellulosic, Acrylic, Polyethylene and Glass,” the company said.
The company said epinephrine injections are used to treat allergic reactions and to increase blood pressure in adults, warning that intravenous administration of the medication “containing particulate matter may lead to serious adverse health consequences.”
Particulate matter can cause life-threatening blood clots, permanent organ damage or death, the FDA explained. Cracked vials can jeopardize sterility, potentially contaminating the medication and posing another health risk for patients.
American Regent is notifying distributors and customers by mail. Consumers, retailers and health care facilities should stop using the product and discard or return it.
The company has so far received no reports of adverse events related to the recall.
Anyone with questions can contact American Regent at 1-800-645-1706, Monday through Friday during standard business hours.
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