NaturaLyte Manufacturer Issues Recall, Citing Unacceptable Bacterial Infection Risk, Reports Baron and Budd

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Fresenius Medical Care North America Recalls 56 Lots of Liquid Bicarbonate Concentrate

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Fresenius Medical Care North America, manufacturer of the dialysis drugs GranuFlo and NaturaLyte, has recalled 56 lots of NaturaLyte due to finding higher bacteria levels than allowed by internal specifications. The company is involved in litigation in a Massachusetts federal court where more than 1,700 lawsuits have been filed in conjunction with a previous recall. (In Re: Fresenius GranuFlo/NaturaLyte Dialysate Litigation, MDL No. 2428)

On May 21, 2014, the U.S. Food and Drug Administration (FDA) issued a safety alert announcing the latest NaturaLyte recall. According to the alert, unacceptable levels of the Halamonas bacteria had been found and the affected drugs should be immediately taken out of use. (, May 21, 2014)

GranuFlo and NaturaLyte are both used to neutralize blood acid levels in patients suffering from kidney failure. GranuFlo is a powder and NaturaLyte is a liquid. At the FDA’s insistence, Fresenius issued a recall in March 2012 for both products after it was revealed they posed a significant risk of causing cardiac arrest in patients. The New York Times published an article stating that Fresenius circulated an internal memo on Nov. 4, 2011 that more than 900 patients being treated at dialysis centers owned by the company had suffered cardiac arrest the previous year. The two products contain high levels of bicarbonate, which were linked to the higher risk of cardiac arrest. (

According to court documents, plaintiffs’ representatives have filed more than 1,700 lawsuits in the U.S. District Court, District of Massachusetts alleging their clients suffered harm due to use of GranuFlo and NaturaLyte. In the lawsuits, plaintiffs allege that Fresenius chose not to alert thousands of dialysis centers not owned by Fresenius about the risks, and that the communications to Fresenius clinics were inadequate. (In Re: Fresenius GranuFlo/NaturaLyte Dialysate Litigation, MDL No. 2428)

“While we applaud the action taken by Fresenius to address unacceptably high bacteria levels, the fact remains that thousands of people have already been harmed due to use of GranuFlo and NaturaLyte,” said Laura Baughman, shareholder of national law firm Baron and Budd. “We will continue to fight on behalf of our clients who suffered catastrophic health problems after trusting their dialysis treatments were safe.”

If you are a patient undergoing dialysis treatment and were harmed, or are the family member of someone who passed away during or shortly after dialysis treatment, you may be able to pursue legal action. Call the national law firm of Baron and Budd at 866-472-9108 or visit for more information.

The attorneys at Baron and Budd have been Protecting What’s Right for consumers for more than 35 years. Over the years, our national law firm has built a successful track record representing people who have been harmed by corporate wrongdoing. The firm’s pharmaceutical lawyers recently represented over 7,000 patients harmed by using the drug Avandia. Previously, Baron & Budd played a prominent role in litigation related to the diet drug Fen-Phen. As a result, the case settled for an amount valued at more than $1.275 billion (In Re Diet Drugs (Phentermine | Fenfluramine | Dexfenfluramine) Products Liability Litigation, MDL No. 1203 (E.D. Pa.).

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Amanda Billo
Baron & Budd
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