Balanced Solutions Voluntarily Recalls Sterile Products
Third compounding pharmacy recalls products due to FDA inspection.
Balanced Solutions Compounding Pharmacy, a division of Axium Healthcare Pharmacy, of Lake Mary, Florida, has announced a voluntarily recall of all lots of its sterile non-expired drug products due to a lack of sterility assurance and concerns with product quality controls, according to FDA. This is the third compounding pharmacy to issue a recall this month. NuVision Pharmacy and ApothéCure announced recalls due to sterility concerns on April 15.
FDA states that during an inspection of Balanced Solutions’ facility investigators observed poor practices and conditions, which may have exposed the company’s sterile products to microbial contamination. Further analysis confirmed FDA concerns. FDA identified gram-negative bacteria, a type of contaminant, in a sample chromium chloride injection from Balanced Solutions. According to FDA, Gram-negative bacteria can cause disease and many types of infection, but the Sphingobacterium thalpophilum bacteria found in the solution does not usually cause infection in humans.
