FDA issues alert for tainted calcium gluconate infusions, linked to Rhodococcus equi bloodstream infections
The U.S. Food and Drug Administration (FDA) alerted health care providers and patients today of a voluntary nationwide recall of all products produced and distributed for sterile use by Specialty Compounding, LLC, Cedar Park, TX.
R. equi long known as an important pathogen of immature horses, has become in the past three decades an opportunistic pathogen of severely immunosuppressed humans.
Image/CDC
There have been recent reports of bacterial bloodstream infections potentially related to the company’s calcium gluconate infusions.
Physicians might prescribe calcium gluconate by infusion to treat conditions associated with low calcium levels in certain circumstances.
This follows a Specialty Compounding voluntary recall issued Friday.
The FDA has received reports of 15 patients from two Texas hospitals who received an infusion of calcium gluconate 2 grams in Sodium Chloride 0.9 percent for Injection, supplied by Specialty Compounding. Then the patients developed bacterial bloodstream infections caused by Rhodococcus equi. 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 says all sterile use products produced and distributed by Specialty Compounding are being recalled and none of these products should be used by patients 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 the products to Specialty Compounding.
“The FDA believes that use of these products would create an unacceptable risk for patients,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “Giving a patient a contaminated injectable drug could result in a life-threatening infection.”
Recalled products were distributed directly to hospitals and physician offices in Texas. Recalled products were also sent directly to patients located nationwide with the exception of North Carolina.
Specialty Compounding is notifying its customers by telephone, fax, electronic mail and/or regular mail of this recall. Users or recipients of these products should immediately discontinue use and return the recalled unexpired products to Specialty Compounding.
To return product or request assistance related to this recall, users should contact Specialty Compounding at 512-219-0724, Monday through Friday, between 10:00 a.m. and 5:00 p.m. CDT.
Rhodococcus equi is a Gram-positive coccobacillus bacterium. The organism is commonly found in dry and dusty soil and can be important for diseases of domesticated animals.
Although R. equi rarely infects immunocompetent humans, it is emerging as an important pathogen in immunocompromised persons. R. equi infections carry an overall mortality rate of about 25%.
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