U.S. FDA warns of problems with EpiPen production plant

 A U.S. regulator this week told Pfizer Inc’s Meridian Medical Technologies division, builder of the EpiPen injector device, that critical member and product failures have been compared with studious deaths and severe illness.
 
Tens of thousands of EpiPens, sole by Mylan NV, were recalled worldwide in Mar following dual reports of the life-saving allergy shot unwell to work in emergencies.

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Pfizer creates EpiPens for Mylan, that has come underneath fire for neatly hiking a cost of a device.
 
“Between 2015 and now, we have shipped some-more than 30 million EpiPen Auto-Injectors globally. It’s not surprising to receive product complaints, generally when a product is frequently administered by non-medically lerned individuals,” Pfizer said in an emailed statement. “We now have no information to indicate that there was any causal tie between these product complaints and any studious deaths.”

In a Sept. 5 warning letter, a U.S. Food and Drug Administration pronounced that a Pfizer section unsuccessful to adequately investigate problems during a production trickery in Brentwood, Missouri, or take suitable visual actions before an FDA inspection progressing this year.
 
In an emailed statement, Mylan said, “Pfizer’s recall several months ago of certain lots of EpiPen Auto-Injector was taken as a active and precautionary magnitude with FDA in relation to these issues.”
 
Both Mylan and Pfizer pronounced they are assured in a safety and efficiency of EpiPen products being constructed during a site.
 
Mylan pronounced it does not now expect any supply issues as a outcome of a warning letter.

The EpiPen is used to provide allergic reactions to certain food and bug bites.

Article source: http://www.cbc.ca/news/health/epipen-fda-1.4280429?cmp=rss