FDA Announced Recall of All Sterile Use Specialty Compounding ProductsAug 12, 2013
All of the products produced and distributed for sterile use by Specialty Compounding, LLC of Cedar Park, Texas are being recalled, according to the U.S. Food and Drug Administration (FDA).
To date, the agency has received reports of illness involving 15 patients from two Texas hospitals who received an infusion of calcium gluconate 2 grams in Sodium Chloride 0.9 percent for injection infusion supplied by Specialty Compounding. The patients developed bacterial bloodstream infections caused by Rhodococcus equi, which are believed to be related to the infusions.
Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding reveal growth of bacteria consistent with Rhodococcus species.
Because of this, all sterile use products produced and distributed by Specialty Compounding are being recalled; none of these products should be used by patients or administered to patients. Facilities, health care providers, and patients who have received the products since May 9, 2013 should immediately discontinue use, quarantine the products, and return the products to Specialty Compounding.
According to information provided by Specialty Products, the recalled products were distributed directly to patients nationwide, with the exception of North Carolina. Recalled products were also distributed directly to hospitals and physicians’ offices in Texas.
“The FDA believes that use of these products would create an unacceptable risk for patients," said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. "Giving a patient a contaminated injectable drug could result in a life-threatening infection.”
Physicians might prescribe calcium gluconate by infusion to treat conditions associated with low calcium levels in certain circumstances. The FDA is working closely with the Centers for Disease Control and Prevention (CDC) and Texas state officials to determine the scope of the contamination.
Adverse reactions experienced with the use of any Specialty Compounding products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax: Online at https://www.accessdata.fda.gov/scripts/medwatch/; download the form at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm or call, toll-free, at 1.800.332.1088 to request a reporting form, then complete and mail the form to the address on the pre-addressed form, or submit by fax to 1.800.FDA.0178.
Compounding involves mixing drugs using bulk ingredients, typically when patients are allergic to inactive ingredients in FDA-approved medications or when a different dose or delivery form—cream, powder, injectable—is required and cannot be commercially filled. Pharmacies are able to work outside of the statutory drug approval process by creating drugs via pharmacy compounding. This means that compounded drugs are not typically FDA approved.