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, according to the FDA’s press release dated March 31, 2017.
Last week, according to Gizmodo, Mylan issued a voluntary recall for one lot of EpiPen Auto-Injectors (5FA665) distributed in Australia, New Zealand, Europe and Japan. This particular lot was not distributed in the U.S.
The recall was initiated after Mylan received two confirmed reports of the devices failing to activate due to a possible defect. Thankfully, the two people trying to use their EpiPens were able to seek medical attention promptly after their devices failed to work and survived.
However, Mylan issued a new recall last night, prompting the FDA press release, reports Gizmodo on Saturday. The new recall not only covers EpiPens sold in the U.S., but also involves the children’s version, known as EpiPen Jr.
EpiPens affected under the new recall were distributed in the U.S. between December 17, 2015, and July 1, 2016. A total of 13 lots is involved in this notice of 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.
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 by downloading and completing the form, then submitting it via fax at 800-FDA-0178.
