F.D.A. Announces Nationwide Voluntary Recall of all Products for Sterile Use from Specialty Compounding

On August 11, 2013, the Food and Drug Administration (F.D.A.) issued a news release notifying the public of the nationwide recall of all products intended for sterile use that were produced by Specialty Compounding, LLC. The company, which is located in Cedar Park, Texas, distributed products to health care facilities across the United States, including Texas. The recall is in response to recent reports that the company’s calcium gluconate injections may have caused bacterial bloodstream infections in 15 patients in Texas. The FDA urges patients, facilities, and health care providers to stop using products from Specialty Compounding, LLC immediately.

The specific product in question, the calcium gluconate injection, is used to treat low calcium levels in certain patients. According to reports provided to the FDA, patients in Texas developed infections in their bloodstreams caused by bacteria known as Rhodococcus equi. A culture sample from a calcium gluconate injection compounded by Specialty Compounding, LLC shows indications of bacteria consistent with Rhodococcus equi.

According to Janet Woodcock, M.D, the director of the FDA’s Center for Drug Evaluation and Research, “The FDA believes that use of these products would create an unacceptable risk for patients. Giving a patient a contaminated injectable drug could result in a life-threatening infection.”

Patients who have any type of adverse symptom should consult their physicians. Likewise, if patients know that they have received an injection from Specialty Compounding, LLC, they should contact their physicians immediately.

See the F.D.A. News Release: