FDA Reminds Health Care Workers Not to Use Sterile Drugs from Medaus

The agency is concerned that the products may pose serious risks to patients

According to a news release, the FDA is reminding health care professionals not to use drugs intended to be sterile that were produced by Medaus Inc., due to lack of sterility assurance. The agency has since issued a request to the pharmacy to recall all non-expired lots of drug products intended to be sterile.

“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.”

The majority of Medaus’ drug products are hormone replacement products, such as inectables and implantable pellets.

An investigation into the company’s facility observed unsanitary conditions, including poor sterile production practices.

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  • OHS Magazine Digital Edition - January 2019

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