FDA: Urgent Care's Injectable Drugs May Lack Sterility

  1. From ANA news:

    11/19/02
    The Food and Drug Administration has announced a nationwide alert concerning all injectable drugs prepared by Urgent Care Pharmacy of Spartanburg, SC. The alert is based on the lack of assurance that its products are sterile. According to the FDA, non-sterility of injectable products can represent a serious hazard to health that could lead to life-threatening injuries and death. Inspection of Urgent Care's facility revealed the company failed to have adequate controls to ensure necessary sterility. The agency reports that on Sept. 16 Urgent Care recalled all lots of its injectable methylprednisolone acetate based on reports of four patients who developed a rare life-threatening infection of the lining of the brain and spinal cord after use of their product. One patient died. The FDA is aware that Urgent Care has distributed injectable drugs to physicians, hospitals, clinics and consumers in Connecticut, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Mississippi, New Hampshire, North Carolina, South Carolina and Virginia. For more information, visit
    www.fda.gov/medwatch/how.htm.
    Last edit by NRSKarenRN on Nov 20, '02
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