The U.S. Food and Drug Administration is alerting health care professionals and patients not to use unexpired drug products that are intended to be sterile that were produced by Medaus Pharmacy in Birmingham, Alabama, due to lack of sterility assurance. Medaus’ products were distributed nationwide and internationally.

Health care professionals and patients should immediately check their medical supplies, quarantine any drug products marketed as sterile from Medaus, and not administer them.

During FDA’s recent inspection of Medaus’ facility, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about Medaus’ ability to assure the sterility of drug products that it produced. Administration of a non-sterile product, intended to be sterile, may result in serious and potentially life-threatening infections or death.

For the detailed information, please check the link below.

http://www.fda.gov/Drugs/DrugSafety/ucm493865.htm