FDA issues formal request to pharmacies to recall all drugs intended to be sterile from Medaus

May 8 2016

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.

"Patient safety is our top priority and patients deserve drugs that are made under safe conditions," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "We are deeply concerned about the safety of the products made by Medaus and the risks associated with them."

Medaus' drug products intended to be sterile were distributed nationwide and were also exported internationally. The majority of these drugs are hormone replacement products, such as injectables and implantable pellets, and injectable nutritional products, such as vitamins, minerals and amino acids.

During the FDA's recent inspection of Medaus' facility in March 2016, investigators observed insanitary conditions, including poor sterile production practices, which raised concerns about Medaus' ability to assure the sterility of drug products that it produced. FDA recommended that the company recall all non-expired lots of drug products intended to be sterile on March 29, 2016. But, Medaus has refused to do so. On April 1, 2016, the FDA issued a statement alerting health care professionals not to use purportedly sterile drugs from Medaus due to lack of sterility assurance.

To date, the FDA is not aware of reports of illness associated with the use of these products. Patients who have received any drug product produced by Medaus and have concerns should contact their health care professional. The FDA encourages health care professionals and patients to report adverse reactions or quality issues related to the use of these products to the FDA's MedWatch Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.