ISSUE: FDA 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. 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. The recalled products were distributed between November 1, 2014, and September 3, 2015.
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
BACKGROUND: FDA has received reports of several adverse events that are potentially associated with drug products made by Medistat. Medistat voluntarily ceased sterile compounding operations on September 1, 2015. FDA previously inspected Medistat in September 2014 and issued a Form FDA 483.
RECOMMENDATION: Health care professionals should immediately check their medical supplies, quarantine any drug products marketed as sterile from Medistat, and not administer them to patients. Patients who have received any drug products produced by Medistat and have concerns should contact their health care professional.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
You are encouraged to report all serious