The Food and Drug Administration (FDA) is alerting patients, caregivers, and healthcare professionals that the labels attached to some EpiPen 0.3-mg and EpiPen Jr 0.15-mg autoinjectors and their authorized generic versions may block access to the autoinjector and prevent easy access to the product.
Mylan EpiPen manufacturer Pfizer reports that the label sticker on the autoinjector unit may have been improperly applied, causing resistance when removing it from the carrier tube, which is the immediate package that contains the autoinjector. In some cases, the patient or caregiver may not be able to quickly remove the autoinjector from the carrier tube.
The autoinjector and the epinephrine it delivers aren’t affected by this issue and can be used as prescribed. The FDA notes that lifesaving products need to work as designed in emergency situations and that patients and caregivers should inspect their autoinjectors prior to needing them to ensure they can quickly access the product.
Pfizer also advises that patients and caregivers should contact Mylan Customer Relations at (800) 796-9526 if an autoinjector does not slide out easily from the carrier tube or if the label is not fully adhered to the autoinjector.
The company also says that pharmacists should inspect these products before dispensing them to patients to ensure quick access to the autoinjector and should not dispense any product that does not easily slide out of its carrier tube.
The FDA is not aware of any adverse events associated with improperly applied EpiPen or EpiPen Jr autoinjectors or their authorized generics label. As stated on the label, consumers should always seek emergency medical help immediately after using their autoinjector.
The FDA further asks healthcare professionals and consumers to report adverse reactions or quality problems to its MedWatch program.
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