November 18, 2002
NATIONWIDE ALERT ON INJECTABLE DRUGS
PREPARED BY URGENT CARE PHARMACY
- 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.
Urgent Care has refused to voluntarily recall the injectable products listed
below 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:
Bimix 30:1 (Phentolamine mesylate/papaverine)
Super Trimix (Papaverine HCl/phentolamine mesylate/prostaglandin)
Urgent Care injectables are labeled as URGENT CARE PHARMACY 2500 WINCHESTER
PLACE , STE. 106, SPARTANBURG, SC 29301, 800-692-8982.
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.