FDA Warns of Possible Contamination of Sterile Products from Compounding Pharmacy

FDA has alerted healthcare professionals of possible contamination in calcium gluconate infusions produced by Specialty Compounding (Cedar Park, TX). The agency has received 15 adverse event reports by patients in two hospitals that received an infusion of calcium gluconate 2 grams in Sodium Chloride 0.9% for injection. The patients developed bacterial bloodstream infections caused by Rhodococcus equi, and it is believed that the infections arerelated to the infusions. Bacterial growth consistent with Rhodococcus equi was found in cultures taken from Specialty Compounding’s calcium gluconate.

FDA and the Centers for Disease Control and Prevention are working with Texas state officials to investigate the cause of the bacterial infections. FDA is asking healthcare professions to report adverse reactions to FDA’s MedWatch program.