sábado, 10 de agosto de 2013

Drug Safety and Availability > FDA Alerts Health Care Professionals about Sterile Products from Specialty Compounding

Drug Safety and Availability > FDA Alerts Health Care Professionals about Sterile Products from Specialty Compounding

FDA Division of Drug Information: Know the Moment It Happens
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

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. 

For more information, please visit: Specialty Compounding

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