FDA Issues Alert for Nationwide and Canada Recall of NaturaLyte Liquid Bicarbonate Concentrate Due to Potential Health Risk
The U.S. Food and Drug Administration (FDA) has issued an alert for Fresenius Medical Care North America’s (FMCNA) recall of NaturaLyte® Liquid Bicarbonate Concentrate. The company recalled 56 lot numbers of the bicarbonate.
The recall was prompted after laboratory testing revealed potential bacteria (Halomonas) contamination of levels higher than is allowed by the company’s internal shelf-life specifications. The 6.4 liter NaturaLyte® product is intended for use in hemodialysis machines. According to medical literature, the FDA warned that the bacterial contamination of the dialysate may lead to bacteremia or systemic infection.
The company informed the FDA and Health Canada of its voluntary recall when it published its customer notifications on April 10th and May 1st. The customer notifications include a list of the product lot numbers that should be promptly and permanently removed from use and returned.
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