The U.S. Food and Drug Administration is alerting health care - TopicsExpress

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.

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