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FDA is alerting patients, caregivers, and health care professionals that EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may potentially have delayed injection or be prevented from properly injecting due to:
- 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
Please review the full letter from the FDA.
It is important for health care providers, patients, and caregivers to periodically review the EpiPen user instructions and practice using the EpiPen trainer to ensure proper understanding and utilization of the EpiPen auto-injector.
Patients should 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. Pharmacists should inspect the products before dispensing them to patients to ensure quick access to the auto-injector and should not dispense any product which does not easily slide out of its carrier tube or has a raised blue safety release. As stated on the product label, consumers should always seek emergency medical help right away after using their epinephrine auto-injector.
FDA is aware of adverse event reports associated with EpiPen products. FDA asks health care professionals and consumers to report any adverse reactions or quality problems to the FDA’s MedWatch program:
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