Issues with EpiPens prompt FDA alert

On Behalf of | Apr 2, 2020 | Pharmaceutical Litigation

Ohio residents with severe allergies rely on the epinephrine auto-injectors they carry at all times for relief in an emergency. Those who use the EpiPen 0.3mg or EpiPen Jr 0.15mg manufactured by Pfizer should know that the Food and Drug Administration recently issued an alert regarding the products. The FDA alert also applies to the authorized generic versions of these name brand products.

Pfizer, Inc. and Mylan, Inc. recently sent a letter alerting health care professionals, caregivers and patients that the products in question may not function properly when needed. This could put patients’ lives in danger since these devices are most often used in severe and life-threatening situations. It appears at least three problems with the devices exist that could cause them to fail.

If the blue safety release is raised, the unit may activate spontaneously or inadvertently. If an individual uses sideways force in order to remove the blue safety release, the unit could activate spontaneously. Individuals could have problems removing the device from its carrier tube. The letter also warns people that user errors associated with these problems could occur that may cause the device to fail. The FDA indicates there have been incidents regarding these failures reported to the agency.

Ohio residents should be able to rely on these medications to save their lives. If someone who relied on one of the epinephrine auto-injectors identified in the FDA alert did not receive the emergency relief the product is supposed to deliver, he or she may have suffered serious injuries and/or death as a result. It may be possible to pursue restitution for the financial losses and other damages incurred because the product failed.


What to do after a mesothelioma diagnosis
How to fund the war against opioid addiction in your community