General News
Published April 28, 2020
On March 24, 2020, the U.S. Food and Drug Administration (FDA) alerted patients, caregivers, and providers that EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may potentially have a delayed injection or aren’t properly injecting for various documented reasons. The affected EpiPens are manufactured by Mylan.
For detailed information, read the FDA public alert.
EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may potentially have a delayed injection or aren’t properly injecting for the following reasons:
- Device failure from spontaneous activation caused by using sideways force to remove the blue safety release
- Device failure from inadvertent or spontaneous activation due to a raised blue safety release
- Difficulty removing the device from the carrier tube
- User errors:
- The device won’t activate if the blue safety release is in place
- Ensure the needle end (orange end of the device) is in contact with the outer thigh (upper leg) prior to and during activation. The EpiPen device should be administered by swinging and pushing firmly against the outer thigh until it “clicks.” This signals that injection has started.
- Ensure the device is held in place for a minimum of three seconds following activation
What should customers with a prescription for an EpiPen 0.3mg and EpiPen Jr 0.15mg (and the authorized generic versions) do?
- Customers are asked to contact Mylan customer relations at 800-796-9526 if they find an issue with their auto-injector and to obtain a replacement at no additional cost.
- Customers should also periodically review the EpiPen user instructions and practice using the EpiPen trainer to ensure proper understanding and use of the EpiPen auto-injector.
- As stated on the product label, consumers should always seek emergency medical help right away after using their epinephrine auto-injector.
The FDA is also asking providers and customers to report any adverse reactions and quality problems to the FDA MedWatch program:
- Complete and submit the report online at: www.fda.gov/medwatch/report.htm
Download and complete the form, then submit by fax to 800-FDA-0178.
LifeWIse is notifying impacted customers with a letter mailed on April 24, 2020. For more information, please contact your LifeWise representative.