The Food and Drug Administration has sent a warning letter to the facility that manufactures EpiPens after receiving hundreds of letters of complaints about the pens not operating properly, in some cases resulting in people dying after allergic reactions.
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EpiPens are auto-injectors sold by the drugmaker Mylan for use by people with severe allergies. The manufacturer targeted by the letter is Pfizer-owned Meridian Medical Technologies, Inc. in Brentwood, Missouri.
In the letter, the FDA accuses the facility of not properly investigating the complaints and failing to act on them.
In response, Nina Devlin, head of global communications at Mylan, told Consumer Reports that “Pfizer is continuing to work with the FDA to resolve the points raised.”
In addition, another Pfizer spokeswoman, Kimberly Bencker, said the drug company “intends to carefully analyze the FDA’s concerns.”