Baxter is recalling one lot of peritoneal dialysis solution, amid concerns about mold contamination and reports of adverse reactions among patients.
The DIANEAL PD-2 Peritoneal Dialysis Solution recall was announced on March 5, after the company received complaints about particulate matter, which it says turned out to be mold.
A number of adverse patient events have been reported among dialysis patients who were given the solution, but Baxter claims there is no evidence at this time of a causal link between the recall and problems.
The company did not describe the number of adverse events or the severity, but warned that “intraperitoneal administration of a product contaminated with mold could result in life-threatening fungal peritoneal infection or sepsis.” The company believes the contamination was caused by a leak in the container.
The DIANEAL peritoneal dialysis (PD) solution is approved for use with patients who have suffered chronic renal failure and are receiving PD treatments. The recall affects one lot of DANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose 6000mL (Ambu-Flex II), with a lot number of C903799 sold in flexible plastic containers. They have an expiration date of 05/15, product code L5B9710, and NDC number of 00941-0411-11.
The affected lot was distributed to dialysis centers, facilities, distributors and patients between May 2013 and January 2014.
Baxter has notified its customers and instructed them to locate and remove affected products from their inventory. Customers who received the recalled containers can return it to Baxter for credit by calling the Baxter Healthcare Center for Service at (888) 229-0001. Consumers with questions can call Baxter Home Care Services at (800) 284-4060.
Anyone who has experienced an adverse reaction after using solution from the recalled lot should report the incident to the FDA’s MedWatch Adverse Event Reporting Program.
GranuFlo and NaturaLyte Dialysis Recall
The Baxter dialysis solution recall comes about two years after Fresenius, the largest dialysis product provider in the country, notified its facilities that its GranuFlo and NaturaLyte dialysis solutions could cause heart attacks if used incorrectly. The FDA later determined that action to be a GranuFlo and NaturaLyte recall.
Fresenius now faces hundreds of dialysis treatment lawsuits in federal and state courts nationwide, all involving similar allegations that the company failed to provide adequate warnings about the risk of heart problems from GranuFlo or NaturaLyte dialysis solutions.
In April 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for all Fresenius cases filed throughout the federal court system, centralizing all lawsuits before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the witnesses, parties and the courts.
A number of cases have also been filed against Fresenius in Massachusetts state court, where similar centralization has been established to place the litigation before one judge.