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Voluntary recall issued after 15 Texas patients injected with contaminated compounds develop blood infection

Posted: August 12, 2013 |   Comments

( The U.S. Food and Drug Administration announced a nationwide voluntary recall of sterile products from the Texas Specialty Compounding pharmacy in Cedar Park, Texas.

The announcement came after fifteen patients developed bacterial infections in the bloodstream after receiving injections from the facility.

The patients had been given infusions of calcium gluconate, which is a mineral supplement injection used for cardiac arrest, to help with a deficiency in calcium or to treat high levels of potassium.

The bacterial infection in the patients' bloodstream was caused by Rhodococcus equi.

The FDA has increased inspections of compounding pharmacies since September of last year. Last year, injections from the Compounding Center in Massachusetts caused a meningitis outbreak, killing 63 people and sickening another 750.

In March, FDA investigators visited the Cedar Park facility and found questionable testing practices and a lack of some procedures in place to establish drug sterility, according to an FDA "483" document detailing the investigation. For example, investigators found improper clothing for people processing drugs and inadequate testing of drugs to make sure the product is free of objectionable microorganisms.

A big problem with the safety of compounding facilities is that there are few laws stating who is actually supposed to regulate these facilities, because of that, there is a serious gap in oversight and inspections. Before the recent deaths, the FDA did not inspect the compounding facilities unless it got complaints or reports of adverse events.

This could change with the Pharmaceutical Compounding Quality and Accountability Act which is currently under consideration in Congress.

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