Dallas, TX compounder NuVision is refusing to voluntarily recall its sterile products, thumbing its nose at FDA requests following safety concerns stemming from a federal inspection of its production facilities this spring. In response, the FDA has issued two public alerts to health care providers not to use any sterile NuVision products and to “quarantine” any supplies in stock.
Shockingly, the FDA has no authority to require a compounding pharmacy to recall any products, even if inspectors have observed lax procedures that could endanger patients. Currently, compounding pharmacies, many of which began as small family-owned operations, are not considered “manufacturers.” But as compounders have flourished, many have become national, high-volume producers. A lapse in sterile procedures at one of these companies has the potential to endanger hundreds, if not thousands, of patients.
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