The compounding pharmacy linked to 17 bacterial infections at two Corpus Christi hospitals says it has found no evidence of contamination in its building or products.
The federal Food and Drug Administration recalled all products produced by Specialty Compounding of Cedar Park after reports of bacterial infections affecting the 17 patients.
Two patients died. But Texas health officials said previously they’d found no link between the recalled medication and the deaths of those who took it before the recall.
The Corpus Christi Caller Times reported Sunday that a representative for Specialty Compounding said the company hired a microbiologist to do its own inspection of the facility and to test samples – including swabbing the noses of pharmacists and technicians working there.
It found no evidence of the bacterium, Rhodococcus equi, found in the blood of 17 people who fell ill at Corpus Christi Medical Center hospitals, Doctors Regional and Bay Area, said David Ball, a spokesman hired by the pharmacy.
“There are literally hundreds of potential sources of contamination,” Ball told the newspaper. “There’s no evidence at this time that the contamination is connected to Specialty Compounding.”
A sample of the pharmacy’s calcium gluconate showed growth consistent with the bacterium found in patients blood, the U.S. Centers for Disease Control and Prevention said in August, citing results from Texas. However, the CDC is still evaluating to confirm that identification.
The FDA says the source of contamination remains under investigation.
Dr. Michael Carome of the consumer advocacy group Public Citizen cautioned against heeding the pharmacy’s findings.
“One should view with skepticism claims by the company until an independent analysis is done by one of the federal officials,” Carome said.
The FDA has said it is concerned about the quality of Specialty Compounding’s sterile products and has urged providers not to administer them.
Corpus Christi Medical Center sequestered all of the company’s products after a hospital lab technician discovered the same unusual bacterium in blood cultures of 17 patients, all of whom received calcium gluconate.
The bacterium commonly is found in dry and dusty soil, and typically causes infections in horses and goats. Infections in humans are rare.
Calcium gluconate is used to treat patients with high potassium levels in their blood, such as those with kidney failure, to protect their hearts.
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