NOV. 19–SPARTANBURG, SC–A nationwide alert instituted by the U.S. Food and Drug Administration (FDA) indicates that all injectable drugs prepared by Urgent Care Pharmacy lack assurance of sterility.

According to the agency, non-sterile injectable products can represent a serious hazard to health that could lead to life-threatening injuries and death. An inspection of Urgent Care’s facility revealed the firm failed to have adequate controls to ensure necessary sterility, including the absence of appropriate testing for potency and sterility prior to distribution.

On Sept.16, Urgent Care recalled all lots of its injectable methylprednisolone acetate after four patients, who were administered the drug, developed a wangiella, a rare, life-threatening fungal meningitis that effects the lining of the brain and spinal cord.

These patients were treated at three different North Carolina hospitals and clinics. Spinal fluid from all of these patients tested positive for a fungus consistent with that found in the Urgent Care product analyzed by both the FDA and Centers for Disease Control and Prevention (CDC). One patient later died despite antifungal therapy.

Urgent Care, the FDA reports, has refused to voluntarily recall any other injectable products they prepared and refused to provide the agency with a complete list of products they distributed.

The FDA is working to identify the recipients of these products so that the agency can directly alert them to the serious risks involved. FDA is continuing to work with the CDC, along with officials from both North Carolina and South Carolina, and will take whatever additional action is needed.

Meanwhile, the South Carolina Board of Pharmacy has issued a cease and desist order to halt further sale of Urgent Care products.

Based on limited information, FDA is aware that Urgent Care has distributed the following injectable drugs to physicians, hospitals, clinics and consumers in Connecticut, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Mississippi, New Hampshire, North Carolina, South Carolina and Virginia: Baclofen; Beta-methasone; Bimix 30:1 (Phentolamine mesylate-papaverine); Clonidine; Estradiol; Hydro-morphone HCl; Fentanyl Methylprednisolone acetate; Morphine Sulfate/Bupivacaine; Papaverine HCl
Super Trimix (Papaverine HCl/phentolamine mesylate-prostaglandin); Testosterone cypionate; and Testosterone/Estradiol