September 11, 2014 — For the third time in the last 15 months, the U.S. Food and Drug Administration (FDA) is demanding a recall of all “sterile” products from NuVision Pharmacy because the safety and sterility of the medications cannot be assured.
No illnesses have been reported, but multiple inspections from the FDA have discovered quality-control problems that might result in contaminated medications on the market.
Inspections in July found sterility failures in 19 lots of supposedly sterile products. Three lots had failures for endotoxins, which are poisons found in certain bacteria that can cause fever, shock, blood pressure changes, circulatory problems, and other severe adverse events. These issues were not investigated or inadequately investigated.
The FDA 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.”
The FDA has stepped up its oversight of the compounding pharmacy industry in the last two years, following an outbreak of fungal meningitis that infected over 750 people, including 63 who died.
Although NuVision has recalled one drug, they are refusing to recall the rest because they claim they do not have to follow FDA standards for drug manufacturing.
The FDA cited the dispute with NuVision when they asked Congress for increased authority and legal options over the compounding industry, according to the Wall Street Journal.
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