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VOLUNTARY RECALL UPDATE: Sterile Products from Specialty Compounding

By Florida Department of Health, Office of Communications

August 16, 2013

FOR IMMEDIATE RELEASE
August 16, 2013

Contact: Communications Office
(850) 245-4111

FLORIDA DEPARTMENT OF HEALTH CONDUCTS PATIENT OUTREACH RELATED TO SPECIALTY COMPOUNDING’S VOLUNTARY RECALL OF STERILE USE PRODUCTS

TALLAHASSEE—The Florida Department of Health (DOH) has confirmed that none of calcium gluconate infusion products potentially linked to bacterial bloodstream infections that were compounded by Specialty Compounding, LLC of Cedar Park, Texas were shipped to Florida. Through shipping records, however, DOH has identified other recalled medications from Specialty Compounding, LLC of Cedar Park, Texas, that were shipped into Florida. Department officials immediately began contacting all patients who received those medications to inform them of the recall and encourage them to actively monitor their health for any signs of infection. At this time, there are no known reports of bacterial infection due to these products in Florida.

The Department, is currently working with the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and Texas state health officials, who are currently monitoring the voluntary recall of all sterile products produced and distributed by Specialty Compounding, LLC.

“Our Department’s top priority is the wellbeing of patients and we are working to inform them of any potential risk associated with these medications,” said Lucy C. Gee, Director of the Division of Medical Quality Assurance. “We will continue to monitor the situation and collaborate with all stakeholders to protect the health and safety of our residents.”

Specialty Compounding’s voluntary recall of products produced for sterile use 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.

Any Florida health care licensee requiring assistance to report a potential adverse reaction following use of these products is encouraged to contact their local county health department.

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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