The US Food and Drug Administration (FDA) posted details of the recall on Friday, explaining Meridian had pulled 13 lots of the allergic reaction drug “due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate.”
The device issue – details of which have not been disclosed – has already seen Mylan recall EpiPens (epinephrine injection, USP) in several countries. The firm’s Meda unit was first to pull the product when it withdrew 499 units in Denmark last month.
Since then the recall has been extended to Japan, Australia and New Zealand with more than 80,000 Epipens being pulled from pharmacy shelves.
Pfizer's Meridian Medical Technologies division makes the auto-injector device at its facility in St. Louis Missouri, US.
A Mylan spokeswoman told us "This recall is being conducted by Meridian Medical Technologies, a Pfizer company, as a result of the receipt of two previously disclosed reports outside of the US of failure to activate the device due to a potential defect in a supplier component. Both reports are related to the single lot that was previously recalled by Meridian.
"The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded by Meridian to include additional lots as a precautionary measure out of an abundance of caution."
The spokeswoman added that: "Testing and analysis across the potentially impacted lots has not identified any units with a defect."