On Monday, Mylan NV’s MYL manufacturing partner Meridian Medical Technologies, who is a Pfizer PFE subsidiary, announced that it will expand its voluntary recall of the EpiPen to the United States after discussing the issue with the Food and Drug Administration (FDA).
This follows Mylan’s recent recall of 81,000 EpiPen devices in countries outside of the U.S. after two reports of the life-saving allergy shot failed to work in emergency situations. Apparently, patients were able to obtain the treatment only after receiving an alternate EpiPen, said Mylan. That recall affected devices distributed throughout Australia, Europe, Japan, and New Zealand.
Mylan believes that the EpiPens being recalled inside the U.S have a defective part like those affected in the initial recall, meaning the autoinjectors will not activate. The generic drug maker cited 13 affected batches of EpiPen 2-Paks and EpiPen Jr. 2-Paks, with expiration dates of April, May, September, and October 2017; these were distributed between December 17, 2015 and July 1, 2016.
“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.
Mylan came under fire last year after it was revealed that the EpiPen underwent staggering price increases over the years in the U.S., and the company is now the focus of multiple federal investigations.
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April 03, 2017 at 11:25PM
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