FDA Warns Health Pros Against Using Products from Downing Labs, NuVusion Pharmacy
The Food and Drug Administration (FDA) continues to advise health professionals against using sterile-use drug products made and distributed by Downing Labs.
The FDA claims that the Texas-based company, that does business under the name NuVision Pharmacy, has not be able to ensure the safety or quality of sterile products. As a result, patients could come down with a serious and potentially life-threatening infection.
After a July inspection, the FDA issued a formal request for the company to immediately recall of the products on the market that are not expired. Inspectors found a sterility failures in 19 lots of drug products intended to be sterile and endotoxin failures in three lots of drug products. There was either inadequate or no investigation into these failures. Endotoxins are substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, and changes in blood pressure and in other circulatory functions.
The FDA alerted health care professionals not to use purportedly sterile drugs from NuVision/Downing Labs due to possible contamination on July 18, 2014. A similar recall request went out after an inspection in 2013.
"We want to assure the public that the compounded lots with failed sterility and endotoxin test results were never released by our pharmacy," wrote NuVision in a statement posted on the company website. The statement went on to say that sterile products are held in quarantine for two weeks while the company waits for results from a third party lab.
According to the statement, "Any products that fail sterility or endotoxin testing are investigated and destroyed by our pharmacy. These products are never dispensed to patients."
Products made at the Downing Labs facility are distributed nationwide.
The FDA advises that patients who have received any drug product produced at the Downing Labs facility and have concerns should contact their health care professional.