Another Compounding Pharmacy in Trouble

All health care facilities and health care providers that have received sterile products from Balanced Solutions should quarantine the products and follow the recall instructions from Balanced Solutions, according to FDA.

The U.S. Food and Drug Administraion announced a voluntary nationwide recall by Balanced Solutions Compounding Pharmacy on April 21, the latest problem for compounding pharmacies nationwide. The ageny's announcement said all sterile non-expired products have been recalled "due to a lack of sterility assurance."

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

All health care facilities and health care providers that have received sterile products from Balanced Solutions should 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," its announcement stated.

FDA said investigators "observed poor practices and conditions, which may have exposed the company’s sterile products to microbial contamination," and additional analysis confirmed problems.

Download Center

HTML - No Current Item Deck
  • Safety Management Software - Free Demo

    IndustrySafe Safety Software’s comprehensive suite of modules help organizations to record and manage incidents, inspections, hazards, behavior based safety observations, and much more. Improve safety with an easy to use tool for tracking, notifying and reporting on key safety data.

  • Create Flexible Safety Dashboards

    IndustrySafe’s Dashboard Module allows organizations allows you to easily create and view safety KPIs to help you make informed business decisions. Our best of breed default indicators can also save you valuable time and effort in monitoring safety metrics.

  • Schedule and Record Observations

    IndustrySafe's Observations module allows managers, supervisors, and employees to conduct observations on employees involved in safety critical behavior. IndustrySafe’s pre-built BBS checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Why Is Near Miss Reporting Important?

    A near miss is an accident that's waiting to happen. Learn how to investigate these close calls and prevent more serious incidents from occurring in the future.

  • Get the Ultimate Guide to Safety Training

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common FAQs.

  • Industry Safe
comments powered by Disqus

OH&S Digital Edition

  • OHS Magazine Digital Edition - May 2019

    May 2019

    Featuring:

    • RESPIRATORY PROTECTION
      Why Pick a PAPR? 
    • FIRE SAFETY TRAINING
      Fire Safety: Plan, Prevent, Train, Recover
    • PROTECTIVE APPAREL
      The Truth About Heat Stress and FRC
    • AIHCE EXP 2019 PREVIEW
      Underestimated No More
    View This Issue