Nationwide Recall of Sterile Products from Specialty Compounding in Texas

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nationwide_sterile_compounding_pharmaceuticals_recallThe U.S. Food and Drug Administration (FDA) has announced a voluntary nationwide recall of all sterile products produced and distributed by Specialty Compounding, LLC, of Cedar Park, Texas. The agency has received reports of bacterial bloodstream infections potentially related to the company’s calcium gluconate infusions.

None of these products should be used by 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 them to Specialty Compounding.

According to information provided to the FDA, the recalled products were distributed directly to patients nationwide, except in North Carolina, and were also distributed to hospitals and physicians’ offices in Texas.

The FDA has received reports of 15 patients at two Texas hospitals who developed bacterial bloodstream infections caused by Rhodococcus equi after receiving an infusion of calcium gluconate 2 grams in Sodium Chloride 0.9 percent for Injection, supplied by Specialty Compounding and the agency believes these infections are related to the infusions. Cultures from an intact sample of the calcium gluconate show growth of bacteria that are consistent with Rhodococcus species.

Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said the agency “believes that use of these products would create an unacceptable risk for patients,” and “could result in a life-threatening infection.”

In the last year, products from a number of compounding pharmacies, particularly sterile injectables, have been linked to infections and disease outbreaks. Last year, more than 50 people died and more than 700 others were sickened in a multistate fungal meningitis outbreak traced to contaminated injections from a Massachusetts compounding pharmacy, the CDC reports.

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 (https://www.accessdata.fda.gov/scripts/medwatch/), by mail or by fax. To request forms by phone, call 1-800-332-1088.