Mylan (NSDQ:MYL) recalled 81,000 EpiPen emergency allergy auto-injectors this week after receiving 2 reports that the device failed to work in emergencies. The recall affects devices in Australia, New Zealand, Europe and Japan, the company reported.
Canonsburg, Penn.-based Mylan said that in both cases, patients received treatment using an alternate EpiPen. The drugmaker also said that it is working with regulatory authorities in affected countries to inform them about the recall.
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.
The new administration’s head of CMS, Seema Verma, said in her confirmation hearing last month that the EpiPen issue is “very disturbing”.
“The idea that perhaps Medicaid programs, which are struggling to pay for those programs, that they could have potentially received rebates is disturbing to me,” she said, according to Reuters.