Fresenius Medical Care issued a recall of its NaturaLyte dialysis medication last month over a bacterial contamination, and the drug maker has now expanded the recall due to a risk of severe injuries or death among dialysis patients. The NaturaLyte recall, which was initially issued in April when the company discovered that its NaturaLyte bicarbonate concentrate was contaminated with a bacteria, was expanded on May 21, and has been classified by the U.S. Food and Drug Administration (FDA) as a Class I recall, which means continued use of the product may lead to severe adverse health outcomes or death. If you believe you have been harmed by a potentially dangerous pharmaceutical drug like NaturaLyte, our consumer advocates at the Consumer Justice Foundation can help put you in touch with a reputable product liability attorney today.
Upon expanding the NaturaLyte dialysis recall, Fresenius indicated that 56 lots of the liquid acid concentrate, which is commonly used in dialysis procedures, was contaminated with a bacteria called Halomonas. According to Fresenius, Halomonas is a Gram Negative bacteria typically found in water with high levels of salt. For patients exposed to the bacteria during NaturaLyte dialysis treatment, side effects could include bacteremia or systemic infection. As a result, 56 lots of NaturaLyte bicarbonate concentrate sold in 6.4 liter bottles have been recalled by Fresenius Medical Care, with the affected lots containing a product code of 08-4000-LB and expiration dates of 6/30/2014, 7/31/2014, 8/31/2014, and 12/31/2014.
In its NaturaLyte recall announcement, Fresenius warns that bacterial contamination during dialysis could lead to pyrogenic reactions to endotoxins present in the bacteria, possibly leading to symptoms like chills, flushing, fever, hypotension and difficulty breathing. Although most of these symptoms are only short-term, bacterial contamination could also lead to long-term health consequences for some patients. As a result, Fresenius has requested that dialysis clinics with recalled bottles of NaturaLyte discontinue use of the products immediately, place the bottles in a secure area, and contact Fresenius for instructions on how to return the medication.
This NaturaLyte recall comes just over two years after it was discovered that Fresenius concealed important safety information about the potential risk of cardiac arrest associated with the use of NaturaLyte and another acid concentrate called GranuFlo, during dialysis treatment. In November 2011, Fresenius sent an internal memo to its own clinics warning doctors that failure to monitor bicarbonate levels during dialysis with GranuFlo or NaturaLyte may lead to higher-than-expected bicarbonate levels and cause patients to suffer devastating side effects like sudden cardiac arrest or death. If you believe you have suffered side effects of GranuFlo or NaturaLyte acid concentrates, contact a product liability lawyer today for legal help.
[box type=”note” align=”aligncenter” ]Source: http://www.fda.gov/Safety/Recalls/ucm398488.htm[/box]