|
 Pfizer, in a regulatory filing, said it would be producing records
in response to the civil investigative demand from the U.S.
Attorney's office for the Southern District of New York.
Meridian, a unit of Pfizer that manufactures EpiPen injectors used
to deliver an emergency allergy antidote, has been hit by a series
of manufacturing problems in recent years. Mylan NV, which markets
EpiPens, has recalled tens of thousands of the devices after
complaints that some had failed to activate.
In 2017, Meridian had received a warning letter from the Food and
Drug Administration. The FDA said Meridian had failed to thoroughly
investigate product failures, including EpiPen products that were
associated with patient deaths and severe illnesses. It said the
company failed to take corrective actions until FDA's inspection.
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Meridian produces all EpiPens sold globally at a single plant near
St. Louis, Missouri.
EpiPen auto-injectors deliver a dose of epinephrine in the event of
severe allergic reaction, such as to bee stings or exposure to
peanuts.
(Reporting by Akanksha Rana in Bengaluru; Editing by Shreejay Sinha)
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