EpiPens distributed in the US being recalled for defect
- Author: Zachary Reyes Apr 02, 2017,
Apr 02, 2017, 3:22
None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies.
According to the company, some of the devices may have a defective part that does not allow for the activation of the injector in case of allergic reaction.
Furthermore, all patients should take comfort in knowing that the whole of this recall is being conducted with full and open supervision of the United States Food and Drug Administration. EpiPens affected under the new recall were distributed in the USA between December 17, 2015, and July 1, 2016.
Mylan's original March 20 recall affected about 80,000 of the EpiPen devices shipped to locations outside the United States. The expanded voluntary recall is being initiated in the US and also will extend to additional markets in Europe, Asia, North and South America.
The notice issued Friday by Mylan N.V. expands upon warnings made earlier this month after two reports of the device failing. The defect occurs rarely and testing did not identify any product lots with a defect.
The defect makes it hard for the EpiPen to work during an emergency and could have significant health consequences for someone who is experiencing an allergic reaction. Mylan bought the EpiPen product in 2007 and then continued to raise the price of the product over the decade to follow-upwards of 600 percent-arguing that maintaining consistent quality of the product was a major reason for the significant price hikes.
The injection is used to counteract unsafe allergic reactions, such as those from bee stings or food allergies.
The recalled items will be replaced at no cost.
Two reported incidents were linked to a single lot, but the company says it's expanding the recall to include additional lots as a precaution.
About 15 million people have food allergies in the USA, and allergic reactions account for about 200,000 emergency room visits per year, according to Food Allergy Research & Education.
Patients should keep the injector in their possession until they have access to the replacement product.