Fresenius Medical Care has expanded its class II recall of NaturaLyte Liquid Bicarbonate Concentrate for hemodialysis because of possible bacterial contamination. In July, the company recalled more than 1.8 million bottles. The recall has now been expanded to include almost 2.3 million bottles.
A Fresenius Medical Care spokesperson told NN&I in July that the product had fallen within acceptable bacterial limits for release into the market, but routine stability testing following distribution indicated that the product may eventually develop bacteria levels that exceed the allowable level.
The expanded lots begin with 15AMLB, 15BMLB, and 15CMLB.
More information on the recall is available in the FDA website.