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The Ohio-based company found particulate matter including glass and nylon in the vials, which can cause blood clots, organ damage, or death
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American Regent announced a voluntary nationwide recall on Thursday covering three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi-dose vials, citing customer complaints about vials that leaked or cracked and could no longer be guaranteed sterile.
Testing conducted during the company's investigation turned up particulate matter inside the vials, with identified materials including nylon, cellulosic, acrylic, polyethylene, and glass, the company said. When injected intravenously, such particles put patients at risk for vascular blockages, loss of blood flow to critical organs, fatal pulmonary embolism, irreversible organ damage, or death, the company warned. Vials that are cracked create an opening for contamination that would not be present in an intact container, introducing a separate hazard for patients, the company said.
