Do you know what an EpiPen is? If you have severe allergies then you are probably very familiar with the device. This auto injector delivers a dose of epinephrine into the body to counteract a sudden allergic reaction. This can be a lifesaver for people afflicted with severe allergies, but what would happen if part of this device malfunctioned and prevented the injection? A new EpiPen defect may do just that, and the Food and Drug Administration isn’t pleased with Meridian Medical Technologies’ response to the problem.
A New EpiPen Defect Could Prove Deadly
Mylan has a deal with the manufacturer Meridian Medical Technologies Inc. — a unit of Pfizer Inc. The company produces Mylan’s EpiPen from a factory located in Brentwood, MO and on February 20th, the FDA sent inspectors to that factory. This inspection lasted for a little over a month, and what these inspectors uncovered has led to FDA action.
A warning letter sent to Meridian Medical Technologies Inc. from the FDA outlined “significant violations of current good manufacturing practice.” The inspection that lasted through most of March uncovered not only multiple alleged product component failures, but also severe illnesses and patient death allegations as well.
In the letter, the FDA revealed that Meridian discovered these supposed product defects back in February 2016. A unit responsible for delivering the injection of epinephrine was not working, so the company rejected that lot. Later, another unit was rejected and the company started an investigation, however, production of the auto injectors continued. In May 2016, an investigation into a customer complaint revealed the same defect but the company still took no actions.
After 171 complaints from 2014 to 2017, an inspection by the FDA and another round of talks with the FDA, Meridian finally recalled 13 lots of the potentially defective pens. The FDA has now demanded that the manufacturer take steps to improve its investigation procedures as well as the way they handle complaints. However, there are still families all across the country who may have been sickened or even died due to these potentially dangerous rescue devices.