A civil investigation has been launched into Pfizer Inc. over quality issues with its auto-injectors.
Reuters reports that the U.S. District Attorney’s office for the Southern District of New York is investigating Pfizer Inc for quality issues at its Meridian Medical Technologies site, where EpiPens are manufactured.
Mylan NV, which markets Epipens, has previously recalled thousands of EpiPens due to reports that they were failing to activate. Meanwhile, in 2017, Meridian received a warning from the Food and Drug Administration for failure to investigate dangerous product failures.
The investigation is still ongoing.
Epipens are devices designed to inject an emergency dose of epinephrine in the case of a severe allergic reaction.
In 2017, Mylan announced a recall of 13 Epipen lots, distributed between December 17, 2015 and July 1, 2016.
Consumers whose EpiPens are not working properly or are causing adverse reactions are encouraged to submit a report to the FDA’s MedWatch program.
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