More Compounding Pharmacy Bacterial Contamination Recalls
Specialty Compounding is recalling all lots of its unexpired sterile products because patients developed bacterial bloodstream infections after receiving intravenous infusions of calcium gluconate compounded by the company. The infecting pathogen was Rhodococcus equi. The recalled products were distributed through physicians in Texas, and directly to patients in all states except North Carolina.
To date, the 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.