August 12, 2013 — Specialty Compounding, LLC, a Texas compounding pharmacy, has recalled IV infusions of calcium gluconate after 15 people developed life-threatening bacterial infections. The patients were treated at two hospitals in Corpus Christi, Texas. Specialty Compounding is recalling all unexpired sterile compounded medicines dispensed since May 9, 2013.
The U.S. Food and Drug Administration (FDA) reported that the patients were treated with calcium gluconate 2 grams in Sodium Chloride 0.9 percent for injections, which were supplied by Specialty Compounding. These injections are normally prescribed to treat conditions associated with low calcium levels.
According to the FDA:
“Then the patients developed bacterial bloodstream infections caused by Rhodococcus equi. These infections are thought to be related to the infusions. Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding show growth of bacteria that are consistent with Rhodococcus species.”
The bacteria implicated in the outbreak, Rhodococcus equi, is a soil-borne pathogen that is mainly found in domestic animals (horses and pigs). Infections of R. equi are rare in humans, but they most often occur in people with weakened immune systems who breathe the bacteria and develop respiratory infections.
The FDA has been investigating more compounding pharmacies after 63 people died and 749 people were infected with fungal meningitis linked to contaminated epidural steroid injections manufactured by New England Compounding Pharmacy (NECC).
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