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U.S. Department of Health and Human Services

Drugs

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FDA Alerts Health Care Professionals about Sterile Products from Specialty Compounding

The U.S. Food and Drug Administration is alerting health care professionals not to use any sterile products supplied by Specialty Compounding, Cedar Park, TX, because bacterial infections have been potentially associated with contaminated calcium gluconate infusions produced by the company. 

FDA has received reports of 15 adverse events experienced by patients in two hospitals. The 15 patients received an infusion of calcium gluconate 2 grams in Sodium Chloride 0.9% for Injection, which was supplied by Specialty Compounding. The patients then developed bacterial bloodstream infections caused by Rhodococcus equi. These infections are thought to be related to the infusions. Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding show growth of bacteria that are consistent with Rhodococcus species.

Calcium gluconate by infusion can be used to treat conditions associated with low calcium levels in certain circumstances.
 
FDA is working closely with the Centers for Disease Control and Prevention (CDC) and the Texas state officials to investigate the cause of these bacterial infections. Health care professionals should report any adverse reactions to FDA’s MedWatch program either by:
 
  • completing and submitting the report online at www.fda.gov/medwatch/report.htm; or
  • downloading and completing the form, then submitting it via fax at 1-800-FDA-0178.
     

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.