FDA: Lifted Label Defect May Delay Emergency Treatment With EpiPen

At this time, the FDA is not aware of any adverse events related to this issue
At this time, the FDA is not aware of any adverse events related to this issue

The Food and Drug Administration (FDA) has issued a safety communication alerting patients and healthcare providers that for some EpiPen (epinephrine 0.3mg) and EpiPen Jr (epinephrine 0.15mg) auto-injectors, and their authorized generics, the device label may become stuck to the inside of the carrier tube and potentially delay administration. EpiPen and EpiPen Jr are both indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis.

In a Dear Healthcare Provider letter, Pfizer, the manufacturer of the Mylan EpiPen, stated that "the probability of an auto-injector having a label that is not fully adhered is very low (approximately 1 auto-injector out of every 14,286 or 0.007%)". To ensure that the auto-injector can be easily removed from the carrier tube, healthcare providers should inspect the product prior to dispensing; an auto-injector should not be dispensed if the label is not fully adhered or if it does not readily slide out of the carrier tube. Detailed precautionary handling instructions are available here.

At this time, the FDA is not aware of any adverse events related to this issue. Healthcare professionals are urged to report any adverse events or quality problems to MedWatch.

Related Articles

For more information contact Mylan at (800) 796-9526 or visit FDA.gov.