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).
Do I have a Naturalyte Lawsuit?
The Schmidt Firm, PLLC is currently accepting Naturalyte induced injury cases in all 50 states. If you or somebody you know has been injured by Naturalyte, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.
The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.
