NaturaLyte Recall Announced

Washington, DCThe US Food and Drug Administration (FDA) and Fresenius Medical Care North America have announced a recall of 56 lots of NaturaLyte Liquid Bicarbonate Concentrate. NaturaLyte and GranuFlo are already the subject of litigation, alleging patients suffered serious side effects due to dosing errors. This latest Fresenius Medical Care recall has reportedly been linked to one death.

According to the FDA recall notice (5/21/14), 56 lots of NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liters, were subject to a Class 1 recall. The products, produced in Montreal, Canada, were recalled due to a higher level of bacteria than allowed by the company’s internal specification. Affected lots were manufactured from August 2013 to April 2014.

“According to a few case reports in the medical literature, bacterial contamination of the dialysate may lead to bacteremia or systemic infection,” the FDA notes.

The FDA noted in a separate announcement that use of the recalled product could result in sepsis, bacteremia and death. “The FDA has received one report of death and two reports of injury that may be related to the use of this product,” the agency wrote.

NaturaLyte is used during hemodialysis to treat acute and chronic renal failure. Both it and Granuflo, also made by Fresenius Medical Care, were recalled in March 2012 after they were linked to an increased risk of cardiac arrest. That recall was announced after an internal memo from Fresenius to its own medical care centers was leaked to the FDA. The memo warned about the risk of high bicarbonate levels, potentially putting patients at risk of cardiac arrest.

That memo, however, was only sent to outside medical care centers after the FDA received it, four months after it was sent to Fresenius centers.

Lawsuits have been filed against Fresenius Medical Care, alleging patients suffered serious side effects, including cardiac arrest, or died after having dialysis treatment using NaturaLyte or GranuFlo. Some lawsuits have been consolidated for multidistrict litigation (MDL 2428, In Re: Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation). The lawsuits involve factual questions regarding whether GranuFlo and NaturaLyte were defectively designed or defectively manufactured, and whether Fresenius knew or should have known of the potential risks associated with the products.