September 11, 2014 — For the second time this year, the U.S. Food and Drug Administration (FDA) is warning healthcare professionals not to use “sterile” products from Downing Labs, LLC, doing business as NuVision Pharmacy in Dallas, Texas, because the products may be contaminated.
It is the third warning from the FDA in the last 15 months. The FDA has asked the compounding pharmacy to immediately recall all lots of its unexpired sterile products because the safety of these products cannot be assured. The FDA that the drug-makers did not adequately investigate these failures.
The agency now warns:
“Health care professionals should not use any NuVision/Downing Labs sterile products for their patients because the firm cannot ensure the safety or quality of these products. Administration of a non-sterile drug product may result in serious and potentially life-threatening infection or death.”
Inspections earlier this year discovered sterility failures in 19 lots of products that were supposed to be sterile, including endotoxin failures in 3 lots. Endotoxins are substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure, and in other circulatory functions.
NuVision has already recalled one drug, but they are refusing to recall the rest because they claim the FDA does not have authority to force them to adhere to manufacturing standards for drug-makers.
The sparring match between the FDA and NuVision was cited when the agency asked Congress for enhanced oversight and more legal options when dealing with compounding pharmacies, according to the Wall Street Journal. Another major factor was a massive outbreak of fungal meningitis in 2012 that was traced to one compounding pharmacy in Massachusetts.
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