If you or any of your loved ones have an EpiPen handy, give it a closer look. Mylan, the manufacturer of EpiPens and EpiPen Jr. Auto-Injector, is calling for a voluntary recall of certain models because they're failing to work properly and may not deploy medication effectively.
Last week, Mylan announced a recall that included seven countries outside of the United States, including Norway, Japan, and Australia. However, the latest announcement from the FDA states that a small number of EpiPens distributed stateside aren't activating correctly, which could be life-threatening for those who rely on them in case of severe allergic reactions.
"The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America," Mylan said in a statement.
Gizmodo reports that the defective EpiPen 2-Pak and EpiPen Jr 2-Pak were "distributed between December 2015 and July 2016." The FDA has a complete list of NDC numbers and lot numbers for anyone who needs to crosscheck their EpiPens against the recall. The government agency says that the number of defective pens is small and that anyone who has Mylan's generic EpiPen is safe, since those are not included in this particular recall. You can find lot numbers on the side of the EpiPen packaging.
Anyone with an affected EpiPen can report it to the FDA's Medwatch website. Consumers can get replacement pens, however. Defective pens will be replaced at pharmacies nationwide, but consumers must contact Mylan directly by calling 800-796-9526 or emailing email@example.com before heading to get a new pen. Both Mylan and the FDA insist that consumers keep the defective pens (in case of emergency) until they've gotten replacements, since not every single unit from the 13 lots is malfunctioning.
It's not clear why this batch of 13 lots was not included in the initial recall of over 80,000 units, since Gizmodo adds that the same plant in St. Louis, MO, manufactures all EpiPens and EpiPen Jrs.