The FDA is alerting health care providers, hospital supply managers, and pharmacists that The Compounding Shop of St. Petersburg, FL may lack sterility assurance for sterile drugs produced at and distributed from this site.
After a recent inspection of The Compounding shop, investigators noted poor sterile compounding practices that raised concerns about lack of sterility assurance. If a sterile drug product has microbial contamination, it potentially places patients at risk for serious infection.
The Compounding Shop is recalling all sterile products and is in the process of notifying customers. Health care providers are to quarantine any sterile products from The Compounding Shop and await further instructions regarding the affected products.
For more information, visit the FDA website.