FDA Announces Voluntary Recall of Sterile Products Used to Inject Drugs
Bloodstream infections may be associated with calcium gluconate infusions (August 11)
The FDA is alerting health care providers and patients of a voluntary nationwide recall of all products produced and distributed for sterile use by Specialty Compounding, LLC, Cedar Park, Texas. There have been recent reports of bacterial bloodstream infections potentially related to the company’s calcium gluconate infusions.
All sterile-use products produced and distributed by Specialty Compounding are being recalled, and none of these products should be used by patients or administered to patients, the agency warns. 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 the firm, the recalled products were distributed directly to patients nationwide, with the exception of patients in North Carolina. Recalled products were also distributed directly to hospitals and physicians’ offices in Texas.
The FDA has received reports of 15 patients from two Texas hospitals who received an infusion of calcium gluconate 2 grams in Sodium Chloride 0.9 Percent for Injection, supplied by Specialty Compounding. The patients 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 showed the growth of bacteria that were consistent with Rhodococcus species.
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.
Source: FDA; August 11, 2013.