FDA is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas

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Intravenous products: FDA report “FDA is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA is basing this expanded alert on a recent inspection of the NuVision Dallas facility, during which FDA investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of the company’s sterile drug products. The agency is not aware of any additional adverse event reports associated with other sterile products from NuVision.”

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