Balanced Solutions Voluntarily Recalls Sterile Products - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Balanced Solutions Voluntarily Recalls Sterile Products


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.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality

Click here