Specialty Compounding LLC Recalls All Sterile Product

Megan Brooks


August 12, 2013

Specialty Compounding, LLC, of Cedar Park, Texas, is voluntarily recalling all lots of unexpired sterile medications because of reports of bacterial bloodstream infections potentially related to the company's calcium gluconate infusions, the company announced August 9.

The US Food and Drug Administration (FDA) has advised healthcare professionals not to use any sterile products supplied by Specialty Compounding.

Facilities, healthcare providers, and patients who have received the products "should immediately discontinue use, quarantine the products, and return the products to Specialty Compounding," the agency said.

To date, the FDA has received reports of 15 patients from 2 Texas hospitals who developed bacterial bloodstream infections caused by Rhodococcus equi after receiving an infusion of calcium gluconate 2 g in sodium chloride 0.9% for injection, supplied by Specialty Compounding. Calcium gluconate by infusion can be used to treat conditions associated with low calcium levels in certain circumstances.

"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.

Scope of Contamination Unknown

"The FDA believes that use of these products would create an unacceptable risk for patients," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said. "Giving a patient a contaminated injectable drug could result in a life-threatening infection."

Specialty Compounding said the recalled products were distributed directly to patients nationwide, with the exception of North Carolina, and directly to hospitals and physicians' offices in Texas. The company has not provided further information at this time on how many patients or hospitals received the product, the company's media contact David Ball, from Ball Consulting Group, LLC, told Medscape Medical News.

The FDA is working closely with officials at the Centers for Disease Control and Prevention and Texas state officials to investigate the cause of these bacterial infections and to determine the scope of the contamination.

The company is notifying customers by telephone, fax, electronic mail, and/or regular mail of this recall. To return product or request assistance related to this recall, customers may contact Specialty Compounding at 512-219-0724, Monday through Friday, between 10 am and 5 pm central time.

Healthcare professionals and patients are encouraged to report adverse events related to the use of these or other products to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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