FDA Shuts Down Drug Facility Due to Unsanitary Conditions

Prescription PillsUnique Pharmaceuticals is recalling all non-expired sterile drug products due to concerns about sterility.

The Food and Drug Administration (FDA) asked Unique to issue the recall after an inspection of the Unique Pharmaceuticals facility uncovered problems that could put patients at “an unacceptable risk for serious infection.”

The agency was forced to question the sterility of all drugs produced at the facility when it discovered “unsanitary conditions,” including:

  • sterility failures in several lots of drug products
  • recurring environmental contamination problems
  • poor sterile production practices

According to a statement published on Unique’s website, the recalled products includes all non-expired, supposedly sterile drug products. The company warns that administering a contaminated product may result in life-threatening infections or death.

Unique advises healthcare providers to check their medical supplies immediately and quarantine any of their sterile drug products. At the request of the FDA, Unique Pharmaceuticals has agreed to suspend all sterile compounding operations until the investigation is complete and sufficient corrections are made.

Pharmaceutical companies endanger the lives of thousands of people when they fail to follow procedure. Sick people trust medicine to help them heal, but contaminated drugs can exacerbate an existing illness or cause new health complications.

My Medicine Was Recalled! What Are My Legal Options?

The attorneys at Proffitt & Cox have a long history of defending drug injury victims. If a drug company’s mistake affected your health, call us today. Our legal experience could help you hold negligent drug manufacturers responsible.

Proffitt & Cox, LLP – Columbia Injury Lawyer

Source: http://www.medscape.com/viewarticle/828807

 



Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.