IGMPI India

Fresenius Medical Care AG & Co. KGAA (FMS) has issued a voluntary recall of 56 lots of its NaturaLyte Liquid Bicarbonate Concentrate as a Class I recall. Classified as the most serious type of recall, Class I recalls involve situations in which there is a reasonable probability that use of the affected product would have caused serious health consequences or even death.

NaturaLyte Liquid Bicarbonate Concentrate solution was used in hemodialysis machines in treatment of acute and chronic renal failure. It removes waste products from the blood through a filtering system and returns the uncontaminated matter to the body. The adulterated products were manufactured at FMS's Montreal, Canada facility from Aug 2013 through Apr 2014 and were distributed from Aug 15, 2013 till Apr 7, 2014. The company has published the customer notifications for the same, including the list of the product lot numbers which should be permanently removed from use and returned.

The drug is recalled due to the concerns over bacteria contamination following one report of patient death and two reports of injury. The laboratory testing identified the bacteria as Halomonas (species 1, 2, 3), a Gram Negative bacteria, typically found in water with high salinity, in the product during its shelf life. Bacterial contamination of the dialysate (fluid used in dialysis) may possibly lead to bacteremia (presence of bacteria in the blood), systemic infection or death.