A recall of potentially malfunctioning EpiPens that Mylan first announced for Europe, Japan and Asia has now gone global, including the U.S., with the company retrieving tens of thousands more. Mylan, however, says it has plenty of replacements to avoid any interruptions in supply.
The drugmaker announced the expanded recall of late Friday after the markets closed. According to the FDA, Mylan is voluntarily recalling the 0.3 mg and 0.15 mg strengths of EpiPen and EpiPen Jr. Auto-Injector because of a problem that may keep them from activating. The recall does not include any of its Mylan’s new authorized generic EpiPens, the FDA said.
The first recall was for Japan, Australia and some markets in Europe. Now it has been expanded to the U.S. as well as additional markets in Europe, Asia and North and South America. Mylan did not specify exactly how many of the Pfizer-made pens are being retrieved this time around, only that the recall involves 13 lots, That is more than three times the number of lots recalled last month when it said more than 80,000 pens were involved.
“Mylan has an adequate supply to replace the recalled devices, as well as to continue to supply the market for future demand of new prescriptions,” a Mylan spokesperson said in an email.
The recalls were initially triggered after Mylan received two confirmed reports of pens that failed to activate because of a potential defect in a supplier component, raising concerns some units would malfunction during an emergency. The pens are manufactured by Pfizer’s Meridian Medical Technologies unit in St. Louis, Missouri.
In its announcement Mylan said it “ will replace 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.” It said patients could exchange the recalled units for either an branded EpiPen Auto-Injector or one of its new generic units, depending on what was available at their pharmacy.
The company introduced that generic product last year as one effort to quell growing criticism over how the company raised prices on its epinephrine injector as its grip on the market tightened. But that so far hasn’t stopped the pressure. After a series of Congressional demands and hearings, and a tentative settlement with the Justice Department over Medicaid overcharges, the company this year said the Federal Trade Commission had started a probe.