Drug Information Update - FDA announces Medistat RX’s nationwide voluntary recall of sterile drug products

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

Yesterday, the U.S. Food and Drug Administration alerted health care professionals and patients of a voluntary recall of all non-expired drug products produced for sterile use and distributed nationwide by Medistat RX, LLC, in Foley, Alabama, due to possible contamination. The recalled products were distributed between November 1, 2014, and September 3, 2015.  

Contaminated drugs put patients at risk of serious infection. Health care professionals should immediately check their medical supplies, quarantine any drug products marketed as sterile from Medistat, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

During an ongoing inspection, FDA investigators and Alabama state inspectors observed significant deficiencies that raise concerns about Medistat’s ability to assure the sterility of drug products that it produced. Medistat voluntarily ceased sterile compounding operations on September 1, 2015.

For more information, please visit: Medistat RX