The FDA announced a recall of NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liters made by Fresenius Medical Care North America due to a higher risk for infection. According to the recall, affected lots may develop higher bacteria levels than allowed by the drug maker.
According to reports, lab results identified the bacteria as Halomonas (species 1, 2 and 3), a bacteria usually found in water with high salt concentration.
The recalled product is intended for use in dialysis machines. The list of affected lots can be found at fmcna.com.
According to an earlier study, NaturaLyte and GranuFlo, another similar product, may put patients at risk for serious side effects such as heart attack and death if they are not administered properly to patients.
These products convert to bicarbonate at a much higher rate than other dialysates, and if patients have too much bicarbonate in the blood, they can suffer serious injuries or death.
For more information about a drug recall or to speak with a drug lawyer about a possible drug lawsuit, please contact Flood Law Group today.
