Specialty Compounding, LLC of Cedar Park, Texas announced that it is recalling all lots of sterile medications that are still within their expiration dates. The recall notice was issued following reports that more than a dozen patients at two Texas hospitals were sickened after they received IV infusions of calcium gluconate made by the company.
According to a Food and Drug Administration announcement, 15 patients at Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area hospitals developed bacterial infections after they were treated with calcium gluconate 2 grams in Sodium Chloride 0.9% for Injection produced by Specialty Compounding. The FDA warning stated that “there is a potential association between the infections and the medication,” which had been shipped to patients located nationwide as well as to hospitals and physician offices in Texas.
The FDA stated that cultures taken from calcium gluconate samples that were compounded by Specialty Compounding showed signs of bacterial contamination consistent with the Rhodococcus species. The agency announced that it would work with the Centers for Disease Control and Prevention and health officials in Texas to determine whether the 15 cases of bacterial infection were linked to medications from Specialty Compounding.
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