On March 31, 2017, Mylan issued a voluntary recall of selected lots of EpiPen and EpiPen Jr Auto-injector because of a potential defect could make the device difficult to activate in an anaphylactic emergency. This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component. Both reports are related to a single lot that was previously recalled outside of the U.S. 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. However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution.
The recalled product was distributed from December 2015 through July 2016. None of the recalled lots include the authorized generic for EpiPen Auto-Injector. Mylan is committed to replacing recalled devices at no cost and reassures patients that there will be no additional replacement-related financial burden to them as a result of this recall
How do you know if your EPIPEN® or EPIPEN JR® is affected by this recall?
- Find your LOT # listed on the box or device
- Does your LOT # match any of the impacted LOT Numbers listed below:
- If your LOT # does NOT match, no further action is necessary
- If your LOT DOES match, please call Stericycle at 877-650-3494 to obtain a voucher for your free replacement product. Stericycle also will provide you with a pre-paid return package to ship the product back to Stericycle
- Visit your pharmacy with your voucher information to redeem your free replacement
- Send your recalled product to Stericycle. Do not return any devices affected by the recall until you have your replacement in hand
Stericycle's hours of operation are Monday-Friday, 8:00 am-10:00 pm ET, and Saturday and Sunday 8:00 am-5:00 pm ET.
Link to full Mylan Press release: http://www.mylan.com/EpiPenRecall
If you have any questions to contact the Yale Health Pharmacy at 203-432-0033.