- Mylan's EpiPen manufacturing partner, Pfizer subsidiary Meridian Medical Technologies, has expanded its voluntary recall of the epinephrine autoinjector to include products distributed in the U.S. and other markets after discussions with the Food and Drug Administration.
- As with the recent recall outside the U.S., these EpiPens may have a defective part that could mean that the autoinjectors will not activate.
- With the share price already rattled by the FDA's rejection of Mylan's generic copy of GlaxoSmithKline's Advair (fluticasone/salmeterol) asthma inhaler, the generic specialist's stock has dropped by a further 5% on the U.S. recall news.
Last week, Mylan voluntarily recalled batches of EpiPens in Australia, New Zealand, Japan and Europe after defects were seen in two devices worldwide in a batch of around 80,000 devices. At the time, Mylan stated that none of these batches had been distributed to the U.S. Now, Mylan is having to deal with an expanded EpiPen recall, with the catchment area growing to take in the U.S. and other markets.
While it's not yet clear how many devices this will now involve, Mylan has cited 13 affected batches of both EpiPen 2-Pak and EpiPen Jr 2-Pak, with expiry dates of April, May, September and October 2017 and distributed between Dec. 17, 2015, and July 1, 2016. The recall starts in the U.S. and will stretch to other markets in Europe, Asia and North and South America. No authorized generic versions are affected.
"Mylan is committed to replacing recalled devices at no cost and Mylan would like to reassure patients that there will be no additional replacement-related financial burden to them as a result of this recall," said Mylan in a statement.
While Mylan has faced a lot of pressure over its aggressive pricing strategies, this recall will put into question Mylan's reputation for safety, putting it at risk from competitors coming onto the market. Several competitors are pushing EpiPen alternatives, including Adamis Pharmaceuticals, which has a pre-filled syringe that is under review by the FDA and has been described by Maxim analyst Jason Kolbert as "a better, more user-friendly product (design wise) versus EpiPen, Adrenaclick and AuviQ."