The U.S. Food and Drug Administration (FDA) announced the recall of all products produced by Specialty Compounding of Cedar Park, Texas, after reports of bacterial infections affecting 17 patients at two Corpus Christi hospitals.
Two of the patients who received the drugs died, but Chris Van Deusen, spokesman for the Texas Department of State Health Services, said that the cause of death is not yet known and no link has been established between the medication and the deaths, the Associated Press (AP) reports.
Texas officials told the Centers for Disease Control and Prevention (CDC) that the patients who received calcium gluconate manufactured by Specialty Compounding developed bloodstream infections and that most of the infections were caused by Rhodococcus equi, which causes illness in horses. Though this infection is rarely seen in people, it sometimes occurs in those with weakened immune systems, specifically AIDS patients, according to the AP. The CDC is analyzing bacteria samples from the patients to see if they are all the same strain and from the same source. The CDC expects results next week.
The CDC tested an intact sample of Specialty Compounding’s calcium gluconate and it showed growth of Rhodococcus bacteria species. The company voluntarily recalled all products manufactured and distributed since May 9, though the infections were attributed only to calcium gluconate. The products involved were sent directly to patients nationwide, except in North Carolina, and were also distributed to Texas hospitals and physicians, according to the AP.
Compounding pharmacies have been under serious scrutiny since last fall, when hundreds of people nationwide were infected in a fungal meningitis outbreak linked to contaminated steroid injections for back pain. The outbreak has been blamed for at least 50 deaths and more than 700 illnesses. Compounding pharmacies produce individually formulated medicines for patients who need a medication different from what is commonly available. Oversight of compounding pharmacies normally rests with state pharmacy boards, but recent expansion in the scope of manufacturing and distribution by some compounders has prompted calls for compounders to be regulated by the FDA as other drug manufacturers are, to ensure safe practices, particularly for sterile products.