Possible device malfunctions and use errors may delay or prevent treatment with EpiPen (epinephrine 0.3mg) and EpiPen Jr (epinephrine 0.15mg) autoinjectors, as well as the authorized generic versions. Epipen is indicated for the emergency treatment of allergic reactions (Type 1) including anaphylaxis.

In a letter to healthcare professionals from Pfizer and Mylan, the ways in which administration of the emergency treatment may be delayed or prevented are described. These include device failure from spontaneous activation caused by using sideways force to remove the blue safety release or caused by a raised blue safety release, problems related to removing the device from the carrier tube, and user administration errors.

According to the letter, the device may activate prematurely if the blue safety release is removed using sideways force. This may occur if a user holds the device with only one hand and attempts to remove the blue safety release with their thumb using a lateral force. To avoid this, the blue safety release should be removed by pulling straight up with one hand while holding the device with the other hand.

Additionally, a very limited number of Epipen devices may have a slightly raised blue safety release that may cause the device to activate prematurely. The letter recommends that autoinjectors should be physically inspected and those with a raised blue safety release should not be dispensed. 

In certain cases, some devices may have a slight deformation on the rim of the carrier tube that may make it difficult to remove the device from the tube during an emergency. This issue may affect any EpiPen autoinjector currently on the market in the US that has an expiration date prior to September 2020. To ensure that the autoinjector can be easily removed from the carrier tube, healthcare providers should inspect the product prior to dispensing; an autoinjector should not be dispensed if it does not readily slide out of the carrier tube.

The letter also identifies certain user errors that may delay or prevent treatment based on postmarketing information. These include failing to remove the device from the carrier tube prior to use, failing to remove the blue safety release prior to use, activating the autoinjector upside down resulting in hand injections, failing to apply sufficient force to activate the device, administering at a site other than the outer thigh, and failing to hold the autoinjector in place for a full 3 seconds. Important reminders on correct administration are provided in the letter. 

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To report any device issues or to obtain a replacement at no cost, consumers should contact Mylan Customer Relations at (800) 796-9526. Adverse reactions may be reported to the FDA’s MedWatch program.

For more information visit fda.gov.