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Epinephrine injection recalled over potentially fatal health risks
American Regent said cracked vials and particulate matter could cause contamination, and no adverse events had been reported as of Sept. 3.
- On Thursday, the FDA shared a recall notice from Ohio-based American Regent for three lots of Epinephrine Injection, USP multi-dose vials, citing leaking and cracked vials that compromise sterility across nationwide distribution.
- American Regent's investigation revealed particulate matter including nylon, cellulosic, acrylic, polyethylene, and glass contaminating the product, with cracked vials compromising container integrity and risking patient safety.
- Intravenous administration of contaminated product can cause "serious adverse health consequences," according to the company, including blood vessel blockage, clotting, and potential organ damage or death.
- Patients should immediately stop using affected lots and contact their healthcare provider; as of September 3, American Regent confirmed no adverse event reports related to the recall.
- Distributors and healthcare facilities must return or discard recalled products, while American Regent arranges replacements and supports customers through its Pharmacovigilance line for return and replacement inquiries.
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American Regent's Epinephrine Recall Exposes Fresh Cracks in Injectable Drug Safety
American Regent recalled three lots of hospital-use epinephrine injection after cracked vials and particles including glass, nylon and plastics were found. The multidose vials, distinct from consumer EpiPens, carry risks of blood clots and organ damage if injected. No adverse events reported so far. Hospitals must check inventory immediately.
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Leaning Left3Leaning Right0Center50Last UpdatedBias Distribution94% Center
Bias Distribution
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C 94%
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