The U.S. Food and Drug Administration has notified consumers of a voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr. (epinephrine injection) Auto Injector’s from Meridian Medical Technologies’. These are used for emergency treatment of severe allergic reactions.
The recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.
While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated.
Consumers should keep and use their current EpiPens if needed until they get a replacement. Consumers should contact Mylan at 800-796-9526 or email@example.com with any questions.
As stated on the label, consumers should always seek emergency medical help right aware after using an Epipen, particularly if the device used does not activate.
At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.
If you have an Epipen and would like to check to see if yours is included, click here for the list.
The FDA asks health care professionals and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program, by:
- Completing and submitting the report online at www.fda.gov/medwatch/report.htm, or
- Downloading and completing the form, then submitting it via fax at 800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Recall Source: FDA