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Saturday, September 13, 2014

FDA Asks Recalcitrant Compounder to Recall Products, Again

Today's post was shared by Take Justice Back and comes from

FDA officials have asked a compounding pharmacy with which they have repeatedly sparred to recall all of its sterile products over concerns that medicines that are currently circulating may be contaminated and present a risk of illness or injury, according to a letter sent yesterday to Downing Labs, which operates NuVision Pharmacy in Dallas, Texas.
The move comes after the FDA found a host of problems during an inspection earlier this summer and warned health care providers and consumers not to use the medicines made by the compounder. In fact, this was the third such warning in 15 months that the agency issued about NuVision and the safety of its compounded drugs.
“Given the high rate of contamination, there is a high probability that contaminated units from other purportedly sterile drug product lots produced at the Downing Labs facility are currently in distribution,” the FDA wrote in what the agency calls a ‘formal request.’ “Based on the inspectional findings, FDA has serious concerns about the conditions and practices at the facility for the production of sterile drugs, which result in a lack of sterility assurance.”
The letter goes on to cite various manufacturing problems, such as a lack of “sound scientific data” to support explanations for sterility failures and an inability to identify the cause of the...
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