80,000 EpiPen Devices Recalled Worldwide

http://www.self.com/story/epipen-devices-recalled-worldwide

Mylan, the makers of the EpiPen, announced on Monday that more than 80,000 units of the EpiPen, the patented device used to dispense a life-saving dose of adrenaline (a.k.a. epinephrine) in cases of severe allergies, have been recalled in multiple countries. The recalled EpiPens could have a defective part that “may result in the device failing to activate,” said a statement issued by Mylan.

A spokesperson for Mylan tells Stat News that EpiPens have now been recalled in Australia, New Zealand, Japan, and several European countries, but the recall does not currently affect those in the United States.

The devices impacted by the recall are labeled with batch numbers 5FA665, 5FA6651, 5FA6652, and 5FA6653. Anyone with a recalled EpiPen can trade it in for a new device free, though Mylan is encouraging all those affected by the recall to keep their current EpiPen until a replacement arrives.

The recall is the latest controversy to besiege Mylan’s EpiPen product. A major price hike issued last year (capping years of increases) led to outcry from private citizens and lawmakers alike. Anger stemmed from both the choice by Mylan to seemingly turn an even greater profit from a life-saving drug, and the revelation that Mylan was engaged in a potentially illegal deal with schools to ensure that educational environments bought only the drug company’s branded product to keep in their facilities—a move that likely contributed to the increase in the EpiPen’s price. Many parents were quick to call out that the EpiPen is “a lifeline, not a luxury.” The price hike by Mylan put the price of the brand-name EpiPen two-pack at over $600. The company then released a generic version costing $300 for two injectors.

Pharmacy chain CVS reacted to the Mylan news last year by announcing the release of a new product, Adrenaclick, at its nationwide pharmacy locations. Adrenaclick retails for $109.99 for those with and without insurance, with CVS’s partner in developing the new product, Impax Laboratories, offering a coupon that would make the product only $9.99 for qualifying customers.

Major insurance company Cigna also reacted to the Mylan price hike by dropping the brand-name EpiPen from coverage by its health insurance plans, saying it would cover only the generic version of the drug.

Filed under: General Problems