NATIONWIDE ALERT ON INJECTABLE DRUGS PREPARED BY URGENT CARE PHARMACY

(SafetyAlerts) - 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:

Baclofen
Betamethasone
Bimix 30:1 (Phentolamine mesylate/papaverine)
Clonidine
Estradiol
Hydromorphone HCl
Fentanyl
Methylprednisolone acetate
Morphine Sulfate/Bupivacaine
Papaverine HCl
Super Trimix (Papaverine HCl/phentolamine mesylate/prostaglandin)
Testosterone cypionate
Testosterone/Estradiol

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.

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Source: FDA