- The American Society of Health-System Pharmacists reported a shortage of EpiPens
- The makers of EpiPen say they are currently shipping the product
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.