EpiPen Manufacturer Under Civil Investigation by US Attorney

EpiPen Shortage

Pfizer’s Meridian unit, responsible for the manufacture of EpiPen and Mylan’s EpiPen Generic, is the subject of a civil investigation by the US Attorney’s office for the District of NY.

The company disclosed in a regulatory filing Thursday that it would be responding to a request for documents related to an investigation of quality issues at the facility.

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These manufacturing issues resulted in the recall of tens of thousands of EpiPens and EpiPen Generics marketed by Mylan and led to an unprecedented shortage of epinephrine auto-injectors that is still ongoing according to the Food and Drug Administration (FDA).

The company received a letter from the FDA in 2017 warning the company that it had failed to thoroughly investigate product failures that were associated with patient deaths and failed to take corrective actions.

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