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Unable to Compel Recall, FDA Asks Doctors Not to Use NuVision’s Products

 
• By Bowman Cox

Dallas compounding pharmacy brushes off FDA’s concerns about sterility assurance despite complaints about one injectable drug product and results of the agency’s inspection. While NuVision asserts compliance with USP requirements, FDA warns physicians that the injectables NuVision compounds may not be sterile.

Because the NuVision pharmacy in Dallas cannot assure sterility of its purportedly sterile products but won't recall them, even after getting an unusual July 26 recall request letter from FDA, the agency has put out a notice asking healthcare providers not to administer the products.

This is from what many consider the world's most powerful pharmaceutical regulatory agency: “NuVision Pharmacy has repeatedly declined to recall its sterile products. The FDA cannot require NuVision to undertake such a recall

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