When Baxter International issued a four-country recall in December of some intravenous products contaminated with particulate matter, it said there had been no reports of adverse events. Same thing in January when it voluntarily recalled three lots of parenteral nutrition products in the U.S. But Baxter couldn't make that claim Wednesday when the company recalled a single lot of a dialysis product in which mold was found. The drugmaker acknowledged that this time, there have been reports of reactions after patients received the solution.
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. 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 did not disclose how many adverse event reports there had been.
The Deerfield, IL-based company started retrieving the product after getting complaints from customers that some of the bags were leaking and particulate was visible in them. The glucose solution is packaged in flexible plastic containers that were distributed throughout the U.S. from May 2013 to January of this year. They went to dialysis centers and other facilities, as well as distributors and patients. Baxter said that particulate matter found in them was identified as mold.
The FDA zeroed in on mold as a particular concern at one of Baxter's plants in a warning letter the drugmaker received last year. In 2012, inspectors said the drugmaker had not been thoroughly cleaning equipment and deposits of mold could be seen clinging to equipment above a large-volume parenteral filling line at a plant in Marion, NC. The agency cited the facility because plant officials never got to the root cause of the mold and so had no idea how to prevent problems in the future. "Without identifying, correcting, and preventing the root cause of the mold growth at your sterile fill lines, the contamination hazard to the products manufactured on those lines could continue and potentially pose risk to patients," the letter said.
- here's the recall notice