Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections
Audience: Pharmacy, Patient, Health Professional
[Update 08/11/2013] FDA News Release is now available.
[Update 08/10/2013] Specialty Compounding, LLC has announced a voluntary nationwide recall of all lots of unexpired sterile products. The recall applies to all unexpired sterile compounded products dispensed since May 9, 2013, including all strengths and dosage forms. The recall was initiated after reports of bacterial infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area, whose treatment included IV infusions of calcium gluconate from Specialty Compounding. There is a potential association between the infections and the medication at this time.
Recalled products were distributed directly to hospitals and physician offices in Texas. Recalled products were also sent directly to patients located nationwide with the exception of North Carolina.
Refer to the Firm Press Release for additional details.
ISSUE: Bacterial infections have been potentially associated with contaminated calcium gluconate infusions produced by Specialty Compounding, Cedar Park, TX.
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.
FDA is working closely with the Centers for Disease Control and Prevention (CDC) and the Texas state officials to investigate the cause of these bacterial infections.
BACKGROUND: Calcium gluconate by infusion can be used to treat conditions associated with low calcium levels in certain circumstances.
RECOMMENDATION: FDA is alerting health care professionals not to use any sterile products supplied by Specialty Compounding, Cedar Park, TX.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[08/11/2013] - News Release - FDA]
[08/10/2013 - Firm Press Release - Specialty Compounding]
[08/09/2013 - Alert - FDA]
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