Recall by Balanced Solutions Compounding Pharmacy Due to Lack of Sterility Assurance

Article

Balanced Solutions Compounding Pharmacy, a division of Axium Healthcare Pharmacy, Inc., of Lake Mary, Fla., is voluntarily recalling all lots of its sterile non-expired drug products due to a lack of sterility assurance and concerns with product quality controls.

Healthcare facilities and healthcare providers that have received sterile products from Balanced Solutions should immediately check their medical supplies, quarantine the products, and follow the recall instructions from Balanced Solutions. Patients who were administered any sterile drug products produced and distributed by Balanced Solutions and who have concerns should contact their healthcare providers.
 
During an FDA inspection of Balanced Solutions, investigators observed poor practices and conditions, which may have exposed the companys sterile products to microbial contamination. The FDAs preliminary findings of sterile production practices and conditions at the site raise concerns about a lack of sterility assurance. This lack of sterility assurance has been confirmed by further FDA analysis. The FDA sampled chromium chloride injection from Balanced Solutions and identified Gram-negative bacteria, a type of contaminant, in the product. 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.
 
Adverse reactions experienced by patients using any products made by Balanced Solutions may be reported to the FDA's MedWatch Adverse Event Reporting program at: www.fda.gov/medwatch/report.htm

Related Videos
Infection Control Today Topic of the Month: Mental Health
Infection Control Today Topic of the Month: Mental Health
An eye instrument holding an intraocular lens for cataract surgery. How to clean and sterilize it appropriately?   (Adobe Stock 417326809By Mohammed)
UV-C Robots by OhmniLabs.  (Photo from OhmniLabs website.)
CDC  (Adobe Stock, unknown)
Laparoscopy(Adobe Stock 338216574 by Damian)
Sterile processing   (Adobe Stock, unknown)
Jill Holdsworth, CIC, FAPIC, NREMT, CRCST, manager of infection prevention at Emory University Hospital Midtown; and Cheron Rojo, BS, FCs, CHL, CIS, CER, CFER, CRCST, clinical education coordinator for sterile processing departments, Healthmark
The Joint Commission Seal
Related Content