August 12, 2013
Voluntary recall of all products for sterile use from Specialty Compounding
The U.S. Food and Drug Administration 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, TX. 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. 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 North Carolina. Recalled products were also distributed directly to hospitals and physicians' offices in Texas.
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.
Full recall here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm364644.htm