The Food and Drug Administration issued the warning after drugmakers Pfizer and Mylan told medical providers that the problems could cause death or serious injuries.
The malfunctions can prevent or delay the devices from injecting the drug or cause them to eject it prematurely. Some users also may have trouble getting the EpiPen out of its carrier tube quickly because of a defect. The problems were found in both EpiPen and EpiPen Jr versions of the product and in their authorized generic versions.
The companies also are urging people who use the products to review the instructions and to contact Mylan Customer Relations at 800-796-9526 for help or free replacements. Pfizer has struggled for a couple years to resolve manufacturing quality problems at its factory that makes EpiPens, resulting in on-and-off shortages since at least 2018. Pfizer said the devices are more consistently available now.
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