![]() ![]() ![]() ![]() Business Insider is first to report on the FDA's 2014 warnings, the action taken by Meridian, and critical details of how Meridian handled the complaints that would lead to the recall.As a result of the FDA's warning letter, new processes at EpiPen factories have contributed to an EpiPen shortage. This occurred as Mylan, the drugmaker that markets and distributes the EpiPen, hiked the price, which sparked controversy.Pfizer responded by saying that "no evidence has been found of a causal link between patient deaths and reports of failure of EpiPen units to activate."."In fact, your own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died," the FDA said in a 2017 letter. ![]() Meridian didn't make significant changes to its complaint-investigation process until three years later, after a major voluntary recall of EpiPens. The manufacturer, Meridian Medical Technologies, didn't properly look into those complaints, FDA inspectors warned as far back as 2014.Complaints about EpiPens not working or arriving in bad shape began to mount in 20.People with life-threatening allergies rely on the EpiPen in emergencies.Account icon An icon in the shape of a person's head and shoulders. ![]()
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