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The Florida Department of Health works to protect, promote & improve the health of all people in Florida through integrated state, county, & community efforts.

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VOLUNTARY RECALL: Sterile Products from Specialty Compounding

By Florida Department of Health, Office of Communications

August 12, 2013

FOR IMMEDIATE RELEASE
August 12, 2013

Contact: Communications Office
(850) 245-4111

FLORIDA DEPARTMENT OF HEALTH MONITORING VOLUNTARY RECALL OF STERILE PRODUCTS FROM SPECIALTY COMPOUNDING

The Florida Department of Health (DOH), in partnership with the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and Texas state health officials, is currently monitoring the voluntary recall of all sterile products produced and distributed by Specialty Compounding, LLC in Cedar Park, TX. At this time there is no evidence that these products were distributed in the state of Florida and the Department is working to verify that the products were not shipped into the state.

The recall was initiated after Texas officials were notified of bacterial bloodstream infections potentially related to the company's calcium gluconate infusions used to treat low calcium levels. Specialty Compounding distributes products to hospitals, physicians’ offices, as well as directly to patients. At this time, there is no known risk to Floridians, but DOH is working vigilantly alongside the FDA, CDC and Texas officials to assess the extent of the potential contamination.

The Department works to protect, promote and improve the health of all people in Florida through integrated state, county and community efforts.

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