The 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. 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.
The FDA has received reports of several adverse events that were potentially associated with drug products made by Medistat. The FDA will continue to work closely with the Alabama Board of Pharmacy to protect the public health.
The FDA previously inspected Medistat in September 2014 and issued a Form FDA 483 which detailed ten observations that showed bad practices. Medistat did not make written records of investigations into unexplained discrepancies, and the failure of a batch or any of its components to meet specifications. Clothing of Medistat personnel engaged in the manufacturing, processing, and packing of drug products was not appropriate for the duties they perform. Routine calibration of equipment was not performed according to a written program designed to assure proper performance. There were no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purported or were represented to possess.
See the FDA Drug Safety Announcement
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication