FDA Alert – Specialty Compounding Products
Friday, August 9th the US Food and Drug Administration (FDA) sent out an alert informing health care professionals not to use any sterile products supplied by Specialty Compounding, Cedar Park, TX. Bacterial infections had been potentially associated with contaminated calcium gluconate infusions produced by the company. FDA had received reports of 15 adverse events experienced by patients in two hospitals; the patients had developed bacterial bloodstream infections caused by Rhodococcus equi, an organism commonly found in dry soil. Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding show growth of bacteria that are consistent withRhodococcus species.
As of Monday, August 11th the FDA announced nationwide voluntary recall of all products for sterile use from Specialty Compounding. The recall applies to all unexpired sterile compounded products dispensed since May 9, 2013, including all strengths and dosage forms.
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.
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