Tuesday, July 22, 2014

FDA Really Wants Dallas' NuVision Pharmacy to Quit Making Drugs Contaminated by Endotoxins

If you more than glance at the website for NuVision Pharmacy, you might start having second thoughts about having the Dallas-based company compound your pharmaceuticals. Why, you might wonder by looking at the home page, did quality testing have to be expanded to check for endotoxins? Why is the "about us" section so keen to point out that the company "is not recalling all sterile injectables." And this "FDA response letter" certainly should give one pause:

There is no evidence to support the FDA's claim that our products lack sterility assurance. ...The FDA did not receive reports about fever, flu-like symptoms, and soreness at the injection site associated with the methylcobalamin injection product. This is information we voluntarily provided to the FDA. The FDA inspectors had no knowledge of this incident prior to our disclosure. ...Neither the FDA nor our pharmacy uncovered any evidence that the symptoms were caused by our product and were not due to an unknown alternative source.

See also: FDA Makes Dallas Supplement Maker Destroy $8 Million Worth of Bodybuilding Powder

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