The FDA has issued a recall for all sterile-use products by a compounding facility in Texas after 15 patients were hospitalized.
The people hospitalized have a bacterial infection in their blood, and doctors believe it is from getting calcium gluconate injections manufactured by Specialty Compounding LLC, based in Cedar Park, Texas.
The FDA believes that use of these products would create an unacceptable risk for patients, according to the FDA's director for drug evaluation and research.
Calcium gluconate infusions are usually given to people which a calcium deficiency or high potassium levels. People with low calcium levels have an increased risk for osteoporosis and bone fractures. High potassium levels can lead to cardiac arrests and death.
The compounding facility told the FDA that products have been delivered directly to patients in every state, except North Carolina. They've also been delivered to hospitals and doctor's offices in Texas.
Compounding pharmacists customize medications to fit an individual's needs. Doctors prescribe these medications when the manufactured drug won't work, i.e. a dosage is too large or a patient has an allergy to an ingredient.
Compounded drugs makes up about 1 percent to 3 percent of the U.S. prescription drug market.
This is not the first compounding facility that has been investigated by the FDA recently. This past year, a compounding pharmacy in Massachusetts was shut down after hundreds were infected with meningitis from contaminated injections, killing 29.
There were also 33 reported cases in seven states of a fungal eye infection caused from products mixed in a Florida pharmacy. The same Florida pharmacy was also responsible for the supplements that killed 21 polo horses in 2009.
More often than we would like to think, prescription medication and even over-the-counter medication does more harm than good. A dangerous drug can be properly prescribed yet still cause serious personal injury or even death because of a defect in the way it was made.
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Source: CNN, "Voluntary recall for another compounding facility," Aug. 12, 2013.