Branded Solutions Compounding Pharmacy Recalls All Sterile Non Expiring Drug Products
Posted Apr 23 2013 2:07am
The FDA was at work inspecting another compounding facility after the nightmare that occurred in New England with the deaths related to bacteria meningitis with contaminated compounded drugs. Here’s what the website looked like today..
“Axium Healthcare Pharmacy, Inc. is a nationwide, privately-held "Clinical Specialty Pharmacy" licensed and permitted to operate in all 50 states. Axium Healthcare Pharmacy, Inc. specializes in providing physicians, patients, health plans and other healthcare providers with injectable and oral brand name products.”
Balanced Solutions Compounding Pharmacy (Balanced Solutions), 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.
Health care facilities and health care 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 health care providers.
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. 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.