The FDA has initiated a recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is because some of the devices have not worked when needed. Given that the pen device is used to counteract potentially fatal allergic reactions, Evolve Medical is encouraging family and friends to share this information with those who may not be aware.
Mylan said the recall was prompted by two reports — both occurring outside the United States — of the products’ “failure to activate” because of a potential defect in a component part.
Failure to activate could “have significant health consequences for a patient experiencing a life-threatening allergic reaction,” Mylan said in a news release.
“The incidence of the defect is extremely rare, and testing and analysis across the potentially impacted lots has not identified any units with a defect,” the company added. However, the recall has been expanded out of an “abundance of caution,” Mylan said.
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 protected] with any questions.
Consumers can receive a replacement of the recalled devices for free by calling 877-650-3494.
As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did 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.
Product/Dosage NDC Number Lot Number Expiration Date
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN767 April 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN773 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM631 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM640 May 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 6GN215 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM082 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM072 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM081 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM088 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM199 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM091 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM198 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM087 October 2017
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.
To review the original FDA announcement, please click here.