Medistat Recalls All Sterile Drugs over Contamination Concerns

Medistat Recalls All Sterile Drugs over Contamination Concerns
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September 11, 2015

This week, the U.S. Food and Drug Administration (FDA) alerted health care professionals and patients that Medistat RX is initiating a voluntary recall of all non-expired drug products produced for sterile use due to possible contamination. The recalled products were distributed from Medistat's Alabama headquarters between Nov. 1, 2014, and Sept. 3, 2015.

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.

FDA has received reports of several adverse events that are potentially associated with drug products made by Medistat. Patients who have received any drug products produced by the company and have concerns should contact their health care professional.

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.

Consumers with questions can contact Medistat at (855) 737-2550.