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.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Complete Online Safety Training Courses

    Deliver state-of-the art, online safety training courses to your organization with IndustrySafe Training Management Software. Generate reports to track training compliance and automatically notify learners of upcoming or overdue classes.

  • Easy to Use Safety Inspection App

    Conduct inspections on the go with IndustrySafe’s mobile app. Complete safety audits at job sites and remote locations—with or without web access.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Analyze Incident Data and Maintain OSHA Compliance

    Collect relevant incident data, analyze trends, and generate accurate regulatory reports, including OSHA 300, 300A, and 301 logs, through IndustrySafe’s extensive incident reporting and investigation module.

  • Industry Safe
comments powered by Disqus