Mylan partner Meridian subject of probe

Pfizer Inc. said it has received a request for documents concerning a civil investigation of quality issues involving the manufacturing of auto-injectors at its Meridian Medical Technologies unit in St. Louis.

Meridian makes EpiPen emergency allergy injectors marketed by local drug giant Mylan. Mylan didn’t immediately respond to a request for comment.

Pfizer will be producing records in response to the request by the U.S. Attorney’s Office for the Southern District of New York, the company said in a filing with the Securities and Exchange Commission.

The EpiPen has faced a number of setbacks in recent years.

In early 2017, tens of thousands of the life-saving devices were recalled after reports that they failed to work in an emergency.

Later that year, Meridian received a warning letter from the U.S. Food and Drug Administration for failing to investigate multiple EpiPen failures, “including failures associated with patient deaths and severe illness,” according to the letter.

Meridian also failed to take corrective actions until after an FDA inspection, the warning letter stated.

Mylan, which is run from executive offices in Cecil, fell under scrutiny in 2016 and was accused of price-gouging for increasing the cost of the EpiPen some 500 percent when it controlled about 95 percent of the auto-injector market.

Since then, Mylan’s market share has eroded dramatically as more competitors entered the market and after Mylan introduced its own half-priced version of the EpiPen to quell criticism over soaring prices.