According to the FDA, bacterial infections have been potentially associated with contaminated calcium gluconate infusions, administered in a hospital, and produced by Specialty Compounding, Cedar Park, TX.
The U.S. Food and Drug Administration (FDA) has reported, via its MedWatch service, fifteen adverse events experienced by patients in two hospitals (Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area). The fifteen patients received an infusion of calcium gluconate (2 grams in Sodium Chloride 0.9% for Injection). Calcium gluconate is a mineral supplement and it is used in the treatment of hypocalcemia (presence of low serum calcium levels in the blood).
The alert is due to the patients developing bacterial bloodstream infections caused by a bacterium called Rhodococcus equi. These infections are thought to be related to the infusions.
The infusion was supplied by a company called Specialty Compounding. Laboratory analysis has shown cultures from an intact sample of calcium gluconate produced by Specialty Compounding showing growth of the same bacterium.
The FDA is working closely with the U.S. Centers for Disease Control and Prevention (CDC) and the Texas state officials to investigate the cause of these bacterial infections.