FDA Warns Providers Not to Use Sterile Drug Products by Medaus Pharmacy Due to Lack of Sterility Assurance

On Friday, April 1, 2016, the Food and Drug Administration (FDA) warned providers 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.

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

The Alabama Board of Pharmacy ordered Medaus to cease sterile compounding operations on March 22, 2016. FDA recommended Medaus recall all unexpired drug products that are intended to be sterile. As of today, Medaus has not voluntarily recalled any products. Therefore, FDA issued an alert to providers and patients not to use any products marketed as sterile from Medaus. To date, FDA is unaware of any adverse events associated with drug products made by Medaus.

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

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm.
  • Mail or Fax: 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.

If you need additional information, please contact Ashley McGlone, manager of regulatory affairs, at amcglone@ascrs.org or 703-591-2220.