FDA Alert on Lack of Sterility Assurance of Drug Products From The Compounding Shop

The Food and Drug Administration (FDA) is alerting healthcare providers, hospital supply managers, and pharmacists that the FDAs preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.
 
The FDA has advised the firm that it is in the best interest of public health to take action to remove all sterile products from the market. The Compounding Shop has informed the FDA that it is recalling sterile products and is in the process of notifying customers.

Healthcare providers and hospital staff should immediately check their medical supplies, quarantine any sterile products from The Compounding Shop, not administer them to patients, and await further instructions from the company regarding the recalled products.
 
The FDA is basing this warning on a recent inspection of The Compounding Shop. The investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of The Compounding Shops sterile drug products.

If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients, says Janet Woodcock, MD, director of the FDAs Center for Drug Evaluation and Research. We do not have reports of patient infections. However, due to concerns about a lack of sterility assurance at the facility and out of an abundance of caution, we have advised the firm to remove its sterile products from the market to protect patients.
 
Patients who have received any product produced by The Compounding Shop and have concerns should contact their health care provider.
 
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDAs 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 to 1-800-FDA-0178.

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