May 23, 2014 — The U.S. Food and Drug Administration (FDA) has issued a Class 1 recall for Naturalyte Liquid Bicarbonate Concentrate because it may be contaminated with bacteria. Patients on dialysis who receive contaminated Naturalyte could develop bacterial infections, sepsis, and bacteremia.
Laboratory testing discovered Halomonas bacteria, which is normally found in water with high salt concentration (salinity). The medical literature includes case reports of people who developed bacterial blood infections (bacteremia) after receiving contaminated dialysate solution.
According to the U.S. Food and Drug Administration (FDA) recall announcement:
“The affected lots were produced in its Montreal, Canada facility and are being recalled because they may develop higher bacteria levels than is allowed by the company’s internal specification during their shelf life.”
The recalled Naturalyte was sold in 6.4-liter bottles and sold from August 15, 2013 until April 7, 2014. Fresenius originally recalled 49 lots, then increased the recall to include 56 lots with product code 08-4000-LB and expiration dates of 6/30/2014, 7/31/2014, 8/31/2014, and 12/31/2014.
Patients who are exposed to significant amounts of endotoxins in bacteria can develop pyrogenic reactions. This can lead to complications like fever, hypotension (low blood pressure), flushing, chills, and/or breathing difficulties. Although these side effects are temporary, patients who have severe reactions could develop long-term complications. Large amounts of bacteria in Naturalyte could cause transient bacteremia (blood poisoning).
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