The U.S. Food and Drug Administration (FDA) on Aug. 11 issued a nationwide recall of all products produced and distributed for sterile use by Specialty Compounding, LLC, of Cedar Park, Texas. The FDA cited recent reports of bacterial bloodstream infections potentially related to the company's calcium gluconate infusions
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, healthcare 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 said it received reports of 15 patients from two Texas hospitals (Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area) who received an infusion of calcium gluconate 2 grams in Sodium Chloride 0.9 percent for Injection, supplied by Specialty Compounding. Those patients subsequently developed bacterial bloodstream infections caused by Rhodococcus equi.
"These infections are thought to be related to the infusions," an FDA alert stated. "Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding show growth of bacteria that are consistent with Rhodococcus species. "
If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections.
“Because of the potential association between the hospital-based infections and sterile compounded medications produced by Specialty Compounding, we are voluntarily recalling all sterile products out of an abundance of caution,” said Ray Solano, RPh, pharmacist in charge at Specialty Compounding, in a prepared statement. “We deeply regret the impact this recall has on our patients and the hospitals that we serve, but patient safety must always be our first concern.”
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.
“The FDA believes that use of these products would create an unacceptable risk for patients," said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, in the agency's Aug. 11 alert. "Giving a patient a contaminated injectable drug could result in a life-threatening infection.”
Physicians might prescribe calcium gluconate by infusion to treat conditions associated with low calcium levels in certain circumstances.
The FDA said it is working closely with the Centers for Disease Control and Prevention and Texas state officials to determine the scope of the contamination.
Specialty Compounding is notifying its customers by telephone, fax, email 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.
Adverse reactions experienced with the use of any Specialty Compounding products may be reported to the FDA's MedWatch Adverse Event Reporting program.
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