Mylan has expanded a voluntary Epipen recall to include the United States, reports MedPage Today.
The company, which makes the product through a manufacturing partnership with Meridian Medical Technologies, a Pfizer company, said the recall covers 0.3 mg and 0.15 mg strengths of the auto-injector that were manufactured from December 2015 through July 2016.
The defect that prompted the voluntary recall makes the pen difficult to activate — it either fails to inject or requires extra force to activate the injection. Since the pen is used to reverse life-threatening allergic reactions, the defect is potentially life-threatening.
The recall covers the US, Europe, Asia, North and South America, the FDA said.
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