|Courtesy of Baxter|
Baxter International ($BAX), which has had ongoing contamination issues with some of its intravenous products, is now recalling one lot of a peritoneal product used on dialysis patients. It says the lot is contaminated with mold. The announcement, also sent out by the FDA, says there have been adverse reactions reported.
The company said Wednesday that it was recalling one lot of DIANEAL PD-2 peritoneal dialysis solution with 1.5% dextrose 6000 mL, down to the user level. Peritoneal treatments exchange fluids through a tube permanently attached to a dialysis patient's abdomen.
Baxter said that there had been complaints of particulate matter, identified as mold, that resulted from a leak in the container. While there have been reports of adverse reactions tied to this lot, the drugmaker pointed out that "no causal relationship has been established" so far. It said that the product is packaged in flexible plastic containers and was distributed to dialysis centers, facilities, distributors and patients in the U.S. between between May 2013 and January 2014.
The recall comes even as the FDA has been working with Baxter, Hospira ($HSP) and B. Braun Medical to face down a nationwide shortage of saline and some other IV products. In December, Baxter had to recall four lots of saline, as well as one lot of 5% dextrose injection, in the U.S. and three other countries after particulate matter was discovered in the solutions. The company last year received an FDA warning letter for plants in Jayuya, Puerto Rico, and Marion, NC. The FDA criticized the plant in North Carolina for not getting to the root of mold problems that led it to stop production on its large-volume parenteral line.
- here's the recall notice