Nationwide Alert on Injectable Drugs Prepared by Urgent Care Pharmacy
Drugs Include Testosterone, Estradiol
[WASHINGTON, DC] - The Food and Drug Administration (FDA) is announcing a nationwide alert concerning all injectable drugs prepared by Urgent Care Pharmacy of Spartanburg, South Carolina, based on the lack of assurance that their products are sterile.
Non-sterility of injectable products can represent a serious hazard to health that could lead to life-threatening injuries and death. FDA 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 September 16, 2002, Urgent Care recalled all lots of its injectable methylprednisolone acetate based on reports of four patients who developed a rare fungal (wangiella) meningitis (a life threatening infection of the lining of the brain and spinal cord) after use of their product. These patients were treated at three different North Carolina hospitals/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 has refused to voluntarily recall any other injectable products they prepared and refused to provide FDA with a complete list of products they distributed. 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 Centers for Disease Control, along with officials from both North Carolina and South Carolina, and will take whatever additional action is needed.
In the meantime, the South Carolina Board of Pharmacy has issued a Cease and Desist order to halt further sale of products from Urgent Care.
At the present time, 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:
Super Trimix (Papaverine HCl/phentolamine mesylate/prostaglandin)
Urgent Care injectables are labeled as URGENT CARE PHARMACY 2500 WINCHESTER PLACE , STE. 106, SPARTANBURG, SC 29301, .
Consumers, physicians, and health care workers are urged to examine their drug supplies for any Urgent Care injectable products and immediately discontinue their use. Users should also notify FDA of any complaints or problems associated with these products.
These reports may be made to MedWatch, the FDA?s voluntary reporting program, by phone at 1-800-FDA-1088 or on line at http://www.fda.gov/medwatch/how.htm.
November 15, 2002
Consumer Inquiries: 888-INFO-FDA
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