EpiPen Recall Issued Outside U.S., Due to Risk Emergency Allergy Drug May Not Work

More than 80,000 EpiPens have been recalled, following reports of problems that suggest the emergency allergy drug may fail to properly administer treatment when needed. 

The EpiPen recall was announced this week by Alphapharm, a subsidiary of Mylan, impacting units distributed outside the United States.

A defective part may cause the EpiPen to fail to activate, or require increased force to deploy treatment. To date, no injuries have been reported in relation to the recall, but an EpiPen failure could cause severe and potentially life-threatening injuries for individuals who are having an allergic reaction.

Emergency allergy auto-injectors, or EpiPens, are a critical treatment for individuals with severe allergies or asthma attacks. Many individuals carry an EpiPen at all times to inject epinephrine, a chemical that narrows blood vessels and opens the airways to the lungs, in the event they are having a serious or life-threatening allergy or asthma attack.

The pens contain epinephrine, commonly referred to as adrenaline, a hormone that can reverse severe low blood pressure and increase the heart rate, muscle strength, blood pressure, and sugar metabolism. Treatment of epinephrine can also reverse wheezing, severe skin itching, hives and various other symptoms of an allergic reaction.

The failure of the EpiPen to activate may result in the patient not receiving the required dose of adrenaline and worsening the symptoms of their allergic reaction of asthma attack. In this event the patient could suffer worsened symptoms anaphylaxis or anaphylactic shock, which can be life threatening.

The recall includes an estimated 81,000 EpiPen® 300µgAdrenaline Injection Syringe Auto-Injector that have batch numbers 5FA665, 5FA6651, 5FA6652 or 5FA6653 and anexpiration date of April 2017.

The recalled EpiPens were manufactured in the United States by Meridian Medical Technologies in St. Louis Missouri, USA for Mylan and its Alphapharm unit. They were distributed for sale to pharmacies and healthcare facilities in Australia, New Zealand, Europe and Japan. According to the recall notice, no units sold within the United States are impacted by this recall.

Customers are being asked to contact their pharmacist immediately to receive a free replacement of the recalled EpiPen with another from a different unaffected batch. Mylan recommends that customers not discard their recalled EpiPen until they have replaced it with an alternative.