FDA MedWatch: “Balance Solutions Compounding Pharmacy, LLC announced a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired.”
“During an FDA inspection of Balanced Solutions, investigators observed poor practices and conditions, which may have exposed the company’s sterile products to microbial contamination. The FDA’s preliminary findings of sterile production practices and conditions at the site raise concerns about a lack of sterility assurance.”
Balanced Solutions Compounding Pharmacy is a division of Axium Healthcare Pharmacy, Inc., of Lake Mary, Florida. The recall affects all of its sterile non-expired drug products due to a lack of sterility assurance and concerns with product quality controls. ”The recall is being initiated due to concerns associated with quality control processes, which present a lack of sterility assurance. Patients are at increased risk for infections in the event a sterile product is compromised.”
For more information visit: FDA – Balanced Solutions Compounding Pharmacy Recall
