EpiPens are Being Recalled Due to Potential Defect

Epipens are used in the unfortunate case of a dangerous allergic reaction. If you or a loved one carries an EpiPen or EpiPen Jr. auto-injector check the device’s lot number. A subset of devices distributed between December 2015 and July 2016 have been voluntarily recalled in the United States. After the manufacturer received two reports that EpiPens did not activate as intended.

The two problems were due to a defective part that could potentially make the device difficult to activate in an emergency. Both reports occurred outside the United States, and in both cases, the EpiPen users were able to receive treatment from an alternative device.

The voluntary recall began in mid-March in Europe, Japan, Australia, and New Zealand, and has since expanded into North and South America and other parts of Asia. In the U.S., 13 separate lots—with expiration dates of April, May, September, and October 2017—are included in the recall.

The lots affected in the United States:

5GM631, 5GM640, 6GM082, 6GM072, 6GM081, 6GM088, 6GM199, 6GM091, 6GM198, and 6GM087 (regular EpiPen, 0.3 mg), and 5GN767, 5GN773, and 6GN215 (EpiPen Jr., 0.15 mg).

You should replace Auto-injectors from these lots as soon as possible, says a statement from Mylan, EpiPen’s distributor. But don’t toss them before you get your hands on a new one. “We are asking patients to keep their existing product until they secure their replacement,” says Mylan’s statement. Consumers are to visit mylan.com/EpiPenRecall or call 877-650-3494 for further instructions. Starting today, Mylan says, consumers will begin receiving vouchers to trade in for new replacement products at their local pharmacies. They’ll also receive a container for mailing back the recalled devices.

Replacing your EpiPen

As a replacement, consumers can receive either EpiPen branded auto-injectors or Mylan’s authorized generic equivalent. (None of the currently recalled lots include the generic version.) If your EpiPen is from a lot not in the recall, it does not need replacing before its expiration date, says Christina Ciaccio, MD, assistant professor of pediatrics at the University of Chicago Medical Center. However, she does recommend keeping an eye on the list of affected products, in case the recall expands further.

For anyone who relies on EpiPen and is nervous about the news, Dr. Ciaccio offers some words of reassurance. “Recalls on epinephrine auto-injectors have occurred in the past,” she says, “but overall, the reliability of these devices has been excellent. Companies that manufacture auto-injectors have done an excellent job moving quickly when they discover a problem.” She adds, it is always a good idea to carry more than one auto-injector—for two reasons. “The first is in case the auto-injector misfires, either by user error or manufacturing error,” she says. “The second is in case he or she needs a second injection before arriving at the emergency department.”

If you have any questions, please leave them in the comments section below.