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GranuFlo Lawsuit News: Bernstein Liebhard LLP Comments on Fresenius FDA Warning Letter, as GranuFlo Recall Claims Mount
Date:8/31/2013

New York, New York (PRWEB) August 31, 2013

As GranuFlo lawsuits (http://www.granuflodialysislawsuits.com/) filed in the aftermath of Fresenius Medical Care’s recall of GranuFlo and NaturaLyte dialysis concentrates continue to mount, Bernstein Liebhard LLP notes that another Fresenius entity recently received a Warning Letter from the U.S. Food & Drug Administration (FDA) for problems at a manufacturing plant in Puerto Rico. According to a report from Reuters, the letter cited issues with complaint-handling procedures and labeling at a Fresenius Kabi facility that manufactures blood bags.*

“The FDA was already investigating Fresenius for its handling of the GranuFlo recall. Taken as a whole, these issues are certainly concerning,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently offering free GranuFlo lawsuit evaluations to dialysis patients who suffered cardiac arrest, heart attacks, stroke, sudden cardiac death or other side effects allegedly related to the administration of GranuFlo and NaturaLyte during dialysis treatments.

GranuFlo Recall

This marks the second FDA Warning Letter received by a Fresenius entity since March 2013. That month, Fresenius Medical Care North America was cited by the agency for issues at a plant in Ogden, Utah. That same entity was also behind the GranuFlo recall, which was issued in March 2013 after GranuFlo and NaturaLyte were linked to a rapid and unsafe elevation of bicarbonate, which creates a substantially increased risk of cardiopulmonary arrest and death. The GranuFlo recall was eventually given the FDA’s most serious recall designation, Class
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