
Agency concerned that products may pose serious risks to patients
The U.S. Food and Drug Administration is reminding health care professionals and patients not to use drugs intended to be sterile that were produced by Medaus Inc., due to lack of sterility assurance. The FDA has issued a formal request to the Birmingham, Alabama, compounding pharmacy to recall all non-expired lots of drug products intended to be sterile.
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. Health care professionals should immediately check their medical supplies, quarantine any drug products intended to be sterile from Medaus and not administer them to patients. Ref. Source 4j.