The United States Food and Drug Administration has announced a voluntary recall made by a Texas compounding pharmacy on all of their sterile products. The agency said in a statement that “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, Tex.”
The company first announced the recall last Friday with the FDA following suit with their own press release to make it more widely known.
The recall is due to 15 patients who have developed bacterial bloodstream infections after receiving injections from the company. The patients were given a mineral supplement called calcium gluconate injections. The infection is caused by Rhodococcus equi and is related to the infusions.
According to Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, “Giving a patient a contaminated injectable drug could result in a life-threatening infection.”
The FDA advises that “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.”
More information about the recall can be answered by the company by calling their toll free number 877-AUSTINRX (287-8679).
via reuters
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