Fresenius Medical Care has issued a voluntary class II recall of more than 1.8 million bottles of NaturaLyte Liquid Bicarbonate Concentrate for hemodialysis because of possible bacterial contamination.
A Fresenius Medical Care spokesperson told NN&I that the product, produced in a Montreal, Canada facility, 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. Fresenius is looking into the cause of the issue, and does not expect the recall to affect market supply.
The affected lots begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB. More information on the recall is available in the FDA website.