FDA Advises to Stop Administering Sterile Products from Medaus

The Food and Drug Administration is asking healthcare professionals to stop administering drug products intended to be sterile that were made by Medaus Inc. due to a lack of sterility assurance. Providers in all settings, including urgent care, are urged to check their supplies and quarantine any “sterile” products from Medaus. Some of the drugs (eg, injectable nutritional products) are more likely to be found in urgent care centers than others, such as injectable hormone replacement products. FDA inspectors say they observed “insanitary conditions” during a March 2016 inspection of Medaus facilities. The FDA has not had reports of illness associated with Medaus products, but asks that clinicians who are concerned about any reactions in patients who have received them report those concerns through the MedWatch Adverse Event Reporting program.