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State officials tie Texas pharmacy to bacterial outbreak

November 20
05:46 2013

Associated Press

CORPUS CHRISTI — State health officials have connected a Central Texas compounding pharmacy to a bacterial outbreak that sickened 17 patients in Corpus Christi hospitals earlier this year.

Bacteria found in an unopened bag of sterile drugs at a local hospital was “indistinguishable” from that found in the blood of those sickened, Texas Department of State Health Services spokesman Chris Van Deusen told the Corpus Christi Caller-Times (http://bit.ly/1jj8wko ).

Van Deusen told The Associated Press Tuesday that while state testing had identified the bacterium in the products before, the most recent results showed a “genetic match” between the product and the blood samples of 15 of the patients.

As of Tuesday, Cedar Park-based Specialty Compounding representatives had not received any word from state about the findings, said David Ball, a spokesman for the company.

He pointed out that the company’s own testing and testing by the FDA had not found the particular bacterium.

Those whose blood contained the bacteria — two died — had all received calcium gluconate, an additive in some IV solutions.

The Food and Drug Administration announced a voluntary recall of the company’s sterile products in August.

The bacterium was Rhodococcus equi.

The state finding followed an FDA report released last week that found a dead fungus in one batch of calcium gluconate and five different kinds of bacteria in a batch of calcium gluconate and sodium chloride solution.

It did not find Rhodococcus equi, but the agency concluded after its month-long inspection that the company should not “perform any sterile drug production at this time.”

“The pharmacy’s own testing similarly detected no Rhodococcus equi in its facility, in its products, or on its personnel,” the company said in a prepared statement Tuesday. “For this reason, it seems clear that Specialty Compounding was not the source of the infections.”

The statement said the company is addressing the findings from the FDA’s inspection and is cooperating with federal and state health officials.

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