On 11/2/18, the FDA has sent an alert that the labels attached to some EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product.

 

In a letter from Pfizer, the manufacturer of the Mylan EpiPen, the label sticker on the auto-injector unit may have been improperly applied, causing resistance when removing it from the carrier tube. The carrier tube is the immediate package in which the auto-injector is contained. In some cases, the patient or caregiver may not be able to quickly remove the epinephrine auto-injector from the carrier tube. The issue is with the device label, and not with the device itself or the drug it delivers, epinephrine.

 

AFFECTED PRODUCTS

  • EpiPen® 0.3 mg (EpiPen® NDC 49502-500-02) (Authorized Generic NDC 49502-10202) products with the labeled expiry on the device and carton between June 2018 and February 2020.
  • EpiPen Jr® 0.15 mg (EpiPen Jr® NDC 49502-501-02) (Authorized Generic NDC 49502101-02) products with the labeled expiry on the device and carton between October 2018 and October 2019.

CONTACT AND REPORTING INFORMATION                                      

If an auto-injector does not readily slide out of the carrier tube OR the label is not fully adhered to the auto-injector, contact Mylan Customer Relations at 1-800-796-9526 (Mon.-Friday 8 AM-7 PM. EST) to obtain a replacement device or for any other questions.

**Please click “Previous Bulletin” to see post on August 22, 2018 regarding Epipen shortages and how to obtain alternatives.