FDA Alerts

Precautionary Handling Instructions for certain EpiPen and EpiPen Jr devices

FDA is alerting patients, caregivers and healthcare professionals that the labels attached to some EpiPen 0.3 mg and EpiPen Jr 0.15 mg 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 to healthcare professionals, Pfizer, the manufacturer of the Mylan EpiPen, warns that 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 auto-injector device and the epinephrine it delivers are not affected by this issue and can be used as prescribed. It is vital for lifesaving products to work as designed in an emergency situation, and patients and caregivers should inspect their epinephrine auto-injector prior to needing it to ensure they can quickly access the product.

The letter also describes how to inspect potentially affected products and explains that patients should contact Mylan Customer Relations at 800-796-9526 if an auto-injector does not slide out easily from the carrier tube OR the label is not fully adhered to the auto-injector. Pharmacists should inspect the products with the patient to ensure quick access to the auto-injector and should not dispense any product which does not easily slide out of its carrier tube.

FDA is not aware of any adverse event reports associated with improperly applied EpiPen or EpiPen Jr auto-injectors, or their authorized generics label. As stated on the product label, consumers should always seek emergency medical help right away after using their epinephrine auto-injector.

Affected Products

  • EpiPen 0.3 mg (NDC 49502-500-02) and authorized generic (NDC 49502-102- 02) products with the labeled expiry on the device and carton between June 2018 and February 2020.

  • EpiPen Jr 0.15 mg (NDC 49502-501-02) and authorized generic (NDC 49502- 101-02) products with the labeled expiry on the device and carton between October 2018 and October 2019.

More Alerts

Medication use in the perioperative setting presents unique patient safety challenges compared with other hospital settings. For example, perioperative medication prescribing and administration often bypasses standard safety checks, such as electronic physician order entry with decision support,
Although medications commercially available in oral solid dosage forms are suitable for most patients, there are populations and circumstances that require splitting tablets, crushing tablets, or opening capsules. Inappropriately altering tablets and capsules can result in treatment failure and