EpiPen Problems Lead to Recall Expansion for Products Sold In U.S.

Following an EpiPen recall issued last month for certain lots of the emergency allergy shot distributed outside the United States, the manufacturer now acknowledges that problems may also cause certain EpiPens distributed in this country to fail to properly administer treatments when needed.

An expanded list of recalled EpiPen and EpiPen Jr. auto-injectors was announced by the FDA last week, due to the risk that the devices may fail, which may lead to serious or life-threatening allergic reactions going untreated.

Alphapharma, a division of Mylan, originally disclosed the risk of EpiPen problems on March 24, but suggested that only products distributed outside of the U.S. were impacted. In this latest announcement, the manufacturer identified 13 lots manufactured between December 2015 and July 2016 were distributed in the U.S.

The emergency allergy auto-injectors provide 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 initial recall included an estimated 81,000 EpiPen 300µg Adrenaline Injection Syringe Auto-Injectors with batch numbers 5FA665, 5FA6651, 5FA6652 or 5FA6653 and an expiration date of April 2017. These particular lots were only distributed for sale to pharmacies and healthcare facilities in Australia, New Zealand, Europe and Japan.

However, after further internal review of the products the manufacturer has voluntarily expanded the recall to include 13 additional lots that were sold throughout the United States that may be impacted by the same mechanical failure.

According to the FDA, while there have been few reported mechanical EpiPen failures, the products are being recalled due to the risk of life-threatening and severe allergic reactions going untreated. To date, no injuries or deaths have reported in relation to the recall.

The recall expansion includes EpiPen Jr Auto-Injectors and EpiPen Auto-Injectors sold in either 0.15 mg or .03 mg dosages with lot numbers 5GN767, 5GN773, 5GM631, 5GM640, 6GN215, 6GM082, 6GM072, 6GM081, 6GM088, 6GM199, 6GM091, 6GM198 and 6GM087.

The recalled lots were manufactured in the United States by Meridian Medical Technologies where they were distributed under the Mylan’s EpiPen brand name from December 17, 2015 through July 1, 2016 to pharmacies and healthcare facilities nationwide.

Customers are being asked to continue carrying their EpiPen devices and to not discard them without having a replacement injector. Customers should contact Mylan at 800-796-9526 or email them at customerservice@mylan.com with additional questions or information on how to receive a replacement injector.