On March 29th, 2012, the U.S. Food and Drug Administration (FDA) issued a Class I recall on the drug GranuFlo Dry Acid Concentrate and Naturalyte Liquid Acid Concentrate. (Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.) GranuFlo and Naturalyte are alkaline substances administered to dialysis patients to neutralize the acid that builds up in the blood. The products are administered in conjunction with bicarbonate, and contain acetate, an ingredient that the body converts to bicarbonate. However, GranuFlo and Naturalyte contain far more acetate than rival products and thus result in more bicarbonate in the body. Research shows that high bicarbonate levels can cause a variety of health problems including:

  • Cardiopulmonary arrest
  • Heart problems
  • Metabolic alkalosis
  • Low blood pressure
  • Sudden MI or heart attack
  • Stroke, and
  • Death

An internal memo from Fresenius Medical Care, the manufacturer of Granuflo and Naturalyte, warned that failure to account for an excess of bicarbonate resulting from an ingredient contained in their product, GranuFlo, was associated with “…6 to 8 greater risk of cardiopulmonary arrest and sudden cardiac death in the dialysis facility.”  The memo also stated that 941 patients suffered cardiac arrest inside the Fresenius Clinics in 2010.

If you or any family members have received GranuFlo Dry Acid Concentrate and Naturlyte Liquid Acid Concentrate please give us a call at 1-800-256-7728 for a free consultation and evaluation.

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm309990.htm

Recall Notice

 

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