The move comes 1 week after Mylan recalled 81,000 EpiPen devices in countries outside the U.S. following 2 reports that the allergy auto-injector failed to work in emergency situations.
“While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement,” the FDA wrote.
The recall affects 13 lots of EpiPen devices manufactured by Pfizer‘s (NYSE:PFE) Meridian and distributed by Mylan between Dec. 17, 2015 and July 1, 2016. While the companies initiated the recall in the U.S., Mylan said it extends to Europe, Asia, North and South America.
The EpiPen device made headlines in August, after reports revealed that Mylan hiked the price of the auto-injector 500% in the last decade.
In response to widespread criticism from politicians and lawmakers, Mylan said in August that it would launch a discounted generic version of the device and expand its patient assistance program. In mid-December, the company announced that its generic EpiPen will sell for $300 per two-pack, which is a 50% discount compared to the price of the brand name device.
The company said in October last year that it agreed to pay $465 million to settle claims that it underpaid Medicaid for its EpiPen auto-injector by misclassifying the device as a generic. The Centers for Medicare & Medicaid Services said it spent $797 million on the emergency allergy treatment between 2011 and 2015, including rebates.
Last week, shares in the Canonsburg, Penn.-based company dropped -3% to $40.46 apiece today after the FDA rejected its Abbreviated New Drug Application for the generic version of GlaxoSmithKline‘s (NYSE:GSK) Advair Diskus.