Fresenius Issues NaturaLyte Recall in Canada Due to Bacterial Contamination
Specific lots of a medication used in dialysis have been affected by a voluntary NaturaLyte recall in Canada, according to a notice posted by the country’s health regulators.
An alert published April 5, 2014 by Health Canada indicates that certain batches of the acid concentrate were found to be contaminated with bacteria. Patients who took “NaturaLyte Sodium Bicarbonate Liquid Concentrate” during a dialysis treatment between August 8, 2013 and October 28, 2013 may have taken the affected product, according to the agency, as it has been distributed and sold in hospital and home settings throughout the country. According to Health Canada, the following lots have been affected by this NaturaLyte recall: Lots: 13JMLB004, 13JMLB006, 13JMLB007 and 13JMLB008 in 6.4L and 8L volumes.
Patients receiving dialysis treatment have been advised by regulators to only use NaturaLyte lots not affected by the recall, or use an alternative product. If no other option is available, they have been urged to seek the advice of a healthcare professional.
Health Canada Directs Hospitals to Throw out NaturaLyte Recall Lots of Drug
Hospital and home patient programs have been directed to examine their stock to find out whether they have any of the NaturaLyte recall-affected lots, and to discontinue use immediately if they do and place all units in a secure area.
This is not the first time the safety of this product has been called into question. In June 2012, NaturaLyte was involved in a recall alongside GranuFlo, another dialysis product manufactured by Fresenius, after it was suggested to cause dangerous cardiovascular side effects. The recall, which was categorized as Class I by the U.S. Food and Drug Administration (FDA) was announced after heart injuries associated with the medications, which may include the risk for sudden cardiac death, heart attacks and strokes, were determined to be serious and potentially fatal.
Two months earlier, Fresenius warned the general public that complications from GranuFlo and NaturaLyte may stem from their high amount of an ingredient the body converts to bicarbonate, which may lead to a condition referred to as metabolic alkalosis. According to a notice on March 29, 2012, the company said this may increase a patient’s risk for cardiovascular side effects. GranuFlo and NaturaLyte lawsuits now allege that the public health alert from Fresenius was issued too late, and that thousands of dialysis patients may have already been affected by the drugs.
Filing a GranuFlo or NaturaLyte Lawsuit
Call our Firm to learn more about 2012’s GranuFlo recall, and whether you may be eligible to file a claim over this medication or NaturaLyte. Reach our lawyers directly at (877) 779-1414.