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CORPUS CHRISTI -- The Food and Drug Administration issued a
report today that sheds new light on contaminated medication at
an Austin-based compounding pharmacy.
Specialty Compounding provided tainted Calcium Gluconate to two local hospitals, Doctor's Regional and Bay Area Medical Center.
In August, at least 17 patients were exposed to the IV medication that had been contaminated with bacteria. Two of those patients later died.
Today's report highlighted the subsequent FDA investigation into Specialty Compounding from August to September. The agency tested samples of the medication that was supposed to be sterile.
In samples of the Sodium Chloride and Calcium Gluconate the company recalled as a result of the incident, the FDA discovered mold and five different kinds of bacteria.
That included Kocuria kristinae and Kocuria varians, bacterias normally found on human skin. The FDA also found Gardnerella vaginalis, which usually causes urinary tract infections and other infections in the female reproductive tract. They also found two kinds of Streptococcus bacteria.
"Your goal is to always minimize the risk and to minimize the amount of possible contamination," Buck said. "While I can't say for sure why there are problems with bacteria, there really should not be."
After the FDA shared the results of the report with Specialty Compounding, the company did recall all of its sterile products back in August.
continue to read here
Specialty Compounding provided tainted Calcium Gluconate to two local hospitals, Doctor's Regional and Bay Area Medical Center.
In August, at least 17 patients were exposed to the IV medication that had been contaminated with bacteria. Two of those patients later died.
Today's report highlighted the subsequent FDA investigation into Specialty Compounding from August to September. The agency tested samples of the medication that was supposed to be sterile.
In samples of the Sodium Chloride and Calcium Gluconate the company recalled as a result of the incident, the FDA discovered mold and five different kinds of bacteria.
That included Kocuria kristinae and Kocuria varians, bacterias normally found on human skin. The FDA also found Gardnerella vaginalis, which usually causes urinary tract infections and other infections in the female reproductive tract. They also found two kinds of Streptococcus bacteria.
"Your goal is to always minimize the risk and to minimize the amount of possible contamination," Buck said. "While I can't say for sure why there are problems with bacteria, there really should not be."
After the FDA shared the results of the report with Specialty Compounding, the company did recall all of its sterile products back in August.
continue to read here