Bacterial Infections Linked to Specialty Compounding Products
Specialty Compounding, LLC is recalling any sterile medication that has not reached its expiration date, including all strengths and dosage forms.
This recall is following reports of bacterial infections from potentially contaminated Calcium Gluconate 2g infusions. The FDA had received reports of 15 adverse events experienced by patients in two Texas hospitals: Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area. After patients received an infusion of Calcium Gluconate in Sodium Chloride, they developed bacterial infections caused by Rhodococcus equi.
There is a potential link between the infections and the medication at this time. The FDA is working closely with the CDC and the Texas state officials to investigate the cause of these bacterial infections.
Specialty Compounding is notifying its customers by telephone, fax, electronic mail and/or regular mail of this recall.
For more information call (512) 219-0724 or visit FDA.gov.