The FDA on Tuesday added four months to the expiration dates for certain lots of EpiPens and a generic version as the school year begins with a national shortage of the injection device that can be a life saver for those with intense allergies.
This covers 29 batches of EpiPens, which are made by Mylan, and 25 batches of the generic version made by Pfizer-owned Meridian Medical Technologies.
“This change beyond the approved 20-month shelf life is based on stability data provided by Mylan and reviewed by the FDA,” the FDA said in an email. “To help ensure patient safety, these products, which already have been dispensed to patients, should have been — and should continue to be — stored as labeled.”
So, for example, EpiPen batch No. 6GM599 with an expiration date of May 2018 can now be used through September 2018.
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Batch numbers on the EpiPens with the extended end date are: 6GM481, 6GM502, 6GM504, 6GM506, 6GM507, 6GM512, 6GM669, 6GM599, 6GM685, 6GM766, 6GM767, 7GM026, 7GM045, 7GM048, 7GM054, 7GM164, 7GM172, 7GM173, 7GM272, 7GM191, 7GM200, 7GM201, 7GM203, 7GM204, 7GM212, 7GM213, 7GM360, 7GM361.
If your batch is in the above group, add four months to the expiration date on the box.
Batch numbers on the MMI generics with the extended end date are: 6FM722, 6FM739, 6FM771, 6FM772, 6FM773, 6FM715, 6FM716, 6FM756, 6FM757, 6FM768, 6FM780, 6FM781, 6FM782, 6FM783, 6FM785, 6FM787, 7FM115, 7FM117, 7FM120, 7FM134, 7FM174, 78FM175, 7FM274, 7FM275, 7FM276.
The auto-injectors give the user a dose of epinephrine to help manage an allergy or asthma attack. The National Institute of Allergy and Infectious Diseases recommends those with serious allergies always have at least one auto-injector on them.
According to FoodAllergyBuzz.com’s blog, some public schools require students with severe allergies give the school nurse two auto-injectors.
But there’s been a shortage recently, prompting the FDA’s move on Tuesday.