A dialysis medication involved in a GranuFlo recall two years ago was once again flagged for potential problems this month after some lots of the drug were found to have been contaminated with bacteria, the U.S. Food and Drug Administration (FDA) reports.

The FDA published a notice on May 22nd that relayed a recall announced by Fresenius Medical Care, the manufacturer of NaturaLyte Liquid Bicarbonate. A totaled 56 lots of the acid concentrate “should be permanently removed from use and returned,” according to the alert, due to their potential to develop higher bacteria levels than permitted by the company’s internal specification. Bacteria contained in the batches of NaturaLyte, which were used in hemodialysis machines, was identified as Halomonas, a Gram Negative bacteria that is typically found in water with high salt concentration.The FDA warns on its website that bacterial contamination of the dialysate could lead to bacteremia or systemic infection.

Fresenius Recall Affects Dozens of NaturaLyte Lots

Dialysis customers were notified of the NaturaLyte contamination in notices published on April 10 and May 1. Following this news, patients and healthcare professionals have been asked to report any adverse events pertaining to the acid concentrate to the FDA online or via phone through its MedWatch Safety Information and Adverse Event Reporting Program.

Two years ago, the FDA issued a Class I recall of NaturaLyte and GranuFlo after the medications were suggested to cause sudden cardiac death, heart attacks, strokes and other serious problems. Since the June 2012 action, Fresenius has been blamed for injuries allegedly sustained by hundreds of dialysis patients. Many of these NaturaLyte and GranuFlo lawsuits have been centralized in a federal multidistrict litigation established in the U.S. District Court, District of Massachusetts, court documents indicate, with at least 1,717 cases now blaming their manufacturer for injuries they allegedly sustained. Plaintiffs in these dialysis claims similarly allege Fresenius’ failure to adequately warn about the risks associated with its products, which they say were designed defectively.  It is estimated that 125,000 customer clinics, along with thousands of dialysis centers owned by the company, were distributing GranuFlo and NaturaLyte prior to the FDA recall in June 2012.

Contact a GranuFlo Lawyer

Call our Firm today to learn more about Fresenius recalls, and whether you may be eligible to file a GranuFlo lawsuit.  Contact us now at (877) 779-1414.

Published May 23, 2014 by