Reports of EpiPen shortage unfounded, Mylan says
Despite reports of EpiPen shortages across the United States, one of the companies that manufactures the device said it is shipping the product — “though supplies may vary from pharmacy to pharmacy.”
EpiPen and EpiPen Jr. are devices made to deliver the lifesaving drug epinephrine during emergency treatment of serious allergic reactions, including anaphylaxis. They are made by Meridian Medical Technologies Inc., a Pfizer company, on behalf on Mylan N.V.
“We understand how important this potentially lifesaving product is to patients, and we are working closely with Mylan to monitor supply levels so patients have access to epinephrine auto injector products,” said Steve Danehy, a spokesman for Pfizer.
Although the US Food and Drug Administration has not included the EpiPen devices on its list of medical shortages as of Tuesday evening, the American Society of Health-System Pharmacists listed the product on its shortage list. “Supply constraints” prevented adequate stock, according to the society’s notice.
In early September, the FDA issued a warning letter to Meridian, which is responsible for the Brentwood, Missouri, facility where EpiPen and EpiPen Jr. are made.
The letter cites “significant violations of current good manufacturing practice (CGMP) requirements for combination products.”
In response to the letter, Mylan said that the FDA warning did not “affect Pfizer’s ability to manufacture and supply” products from the facility.