Labels May Interfere with Use of Some Epinephrine Auto-Injectors
November 2, 2018 – The U.S. FDA has issued a safety alert for patients, caregivers, and healthcare professionals that the labels on some EpiPen® 0.3mg and EpiPen Jr® 0.15mg epinephrine auto-injectors, as well as the authorized generic versions, may impede access. The products are manufactured by Pfizer on behalf of Mylan.
Affected products have package labeling that did not fully adhere to the carrier tube, and the label can become stuck inside of the tube. This can make it difficult to remove the auto-injector for use. Although the auto-injector still works properly, patients and caregivers should check the carrier tube to ensure they can quickly and easily access the auto-injector in an emergency. Delays in removing the product from the carrier could risk further progression of a severe allergic reaction in an emergency. An estimated 0.007% of EpiPen, EpiPen Jr, and authorized generic products have been affected.
In a letter to healthcare professionals, Pfizer and Mylan report that they have addressed the source of the labeling problem. The letter advises healthcare professionals to check that auto-injectors can be easily removed from their carrier tubes and that the label has adhered properly before dispensing the product. Any product that fails this check should not be dispensed. Patients should also be counseled on how to check the product for themselves, and advised that this should be done before the product needs to be used. The letter includes precautionary handling instructions to aid healthcare professionals and consumers in these checks.
Potentially affected products can be identified using the following information:
- EpiPen® 0.3mg (EpiPen® NDC 49502-500-02) (Authorized Generic NDC 49502-102-02) products with the labeled expiry on the device and carton between June 2018 and February 2020.
- EpiPen Jr® 0.15mg (EpiPen Jr® NDC 49502-501-02) (Authorized Generic NDC 49502-101-02) products with the labeled expiry on the device and carton between October 2018 and October 2019.
Mylan Customer Relations is available to answer questions regarding label concerns at 1-800-796-9526. For reports of adverse effects or quality issues, Mylan can be reached at 1-877-446-3679. Adverse effects can also be reported to the FDA’s MedWatch program. As of the date of the safety alert, no adverse events had been reported in relation to the labeling concern.
BeneCard PBF’s Member Services is available 24 hours a day, seven days a week, to assist members with any questions they may have about the safety alert’s impact on their epinephrine auto-injector. Members can call the number on the back of their ID card to be connected with a pharmacist who can assist.