Meridian Medical, a Pfizer-owned company and Mylan’s manufacturing partner for the EpiPen, has expanded its recall of the medical device to include lots distributed in the US. The decision to expand the recall of the epinephrine auto-injectors was based on a meeting with the US Food and Drug Administration (FDA).
According to Mylan, the potentially defective auto-injectors may fail to activate in an emergency. Because the combination drug/device is used to treat patients experiencing a life-threatening allergic reaction, the consequences of having a nonfunctional auto-injector could be fatal.
In March, Mylan issued its first recall of specific batches of the EpiPen, which were distributed in New Zealand, Australia, Japan and Europe. The recall was initiated following reports that two EpiPens had failed to activate.
The initial recall affected a batch of approximately 80,000 medical devices. Now that Mylan and Meridian have expanded this voluntary recall to include 13 additional batches, the number of potentially affected devices is likely much higher.
The potentially defective auto-injectors include batches of both the EpiPen 2-Pak and EpiPen Jr 2-Pak, however no authorized generic versions are affected at this time. In addition to some batches in the US being affected by the recall, patients in other parts of North America, South America, Europe and Asia, may also be in possession of affected auto-injectors.
“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 the Mylan press release on the expanded recall. “We are asking patients to keep their existing product until their replacement product can be secured.”
This recall is just the latest in a string of bad press for Mylan. Since 2016, the company has been facing scrutiny over its pricing practices for the EpiPen, which has risen in price to over $600 for a two-pack. Generic competitors – like Impax Pharmaceuticals’ Adrenaclick – are also increasingly looking to secure some of Mylan’s market share for the medical device.