American Regent has recalled three lots of Epinephrine Injection, USP, after leaking and cracked vials were found to contain particulate matter.
The nationwide recall covers three lots of the 30 milligram/30 milliliter product, according to a Sept. 3 FDA news release. The particles were identified as nylon, cellulosic material, acrylic, polyethylene and glass.
Intravenous administration of a product containing particulate matter could cause serious adverse health consequences, including blockage of blood vessels, blood clotting, pulmonary embolism, organ damage and death.
American Regent has not received any reports of adverse events associated with the recalled lots. Customers were instructed to stop using the affected products and either return or discard them.
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