Texas Company Recalls Sterile Use Products

Sterile Compounding of Cedar Park has voluntarily recalled all products it produced and distributed for sterile use because of reports of bacterial bloodstream infections possibly related to the company's calcium gluconate infusions.

The U.S. Food and Drug Administration (FDA) said in a news release that it "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. Then 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 show growth of bacteria that are consistent with Rhodococcus species."

The FDA said 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. Facilities, health care providers, and patients who have received the products should immediately discontinue use, quarantine the products, and return the products to Specialty Compounding."

The FDA said the firm told it 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."


Action, Aug. 16, 2013


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