FDA Alerts Patients, Providers Regarding Product Recall by Texas Compounding Facility

The Food and Drug Administration is working closely with the Centers for Disease Control and Prevention (CDC) and Texas state officials to determine the scope of contaminations that originated at Specialty Compounding, LLC, located in Cedar Park, Texas.  A voluntary nationwide recall of all products produced and distributed for sterile use by the facility was issued after 15 patients, who received injections of calcium gluconate supplied by the company, developed bacterial bloodstream infections.

Cultures taken from a sample of calcium gluconate compounded by Specialty Compounding have produced bacteria consistent with the Rhodococcus species that caused the patients’ infections.

The company has indicated that the recalled products were distributed directly to patients in every state with the exception of North  Carolina as well as through hospitals and physicians’ offices across the state of Texas.  Any facilities, healthcare providers or patients who have received the products since May 9, 2013 should immediately discontinue use, quarantine the products and return them to Specialty Compounding.

To read the press release announcing this serious product recall and to learn more, click here.