Hylenex Recall: Baby Rehydration Fluids Contaminated with Glass Flakes

Baxter International Inc. is recalling about 3,200 vials of Hylenex, a pediatric rehydration medication, due to glass flake contamination. Halozyme Therapeutics, a company partnered with Baxter to manufacture Hylenex, has issued a breach notice against Baxter and is threatening to terminate their partnership due to the recall. 

The Hylenex recall was announced by Baxter on Monday after the glass-like particulate matter was discovered during stability testing. According to the Baxter press release, there have been no reported injuries or complaints associated with the Hylenex contamination.

Hylenex was approved by FDA in October for use as a means of rehydrating infants and children. Instead of the typical intravenous injection, the drug is delivered subcutaneously, under the skin. Baxter is partnered with Halozyme Therapeutics, which developed the drug delivery technology being used.

On Sunday, Halozyme sent a notice of breach to Baxter, claiming that Baxter’s “manufacturing failures” has led them to be concerned over the company’s capability to provide quality products. If Baxter’s manufacturing problems are not shown to be addressed in 120 days, Halozyme says it can terminate it’s partnership with Baxter.

Baxter has been plagued by a number of major recalls in recent months. Earlier this month, it recalled 200,000 Colleague infusion pumps after federal reviewers found a number of problems with them. In March, Baxter recalled several models of Baxter HomeChoice automated dialysis machines, which were found to overfill patients’ abdominal cavities with fluid. The defective medical devices are believed to have led to the death of at least one patient.

In addition to the recent recalls, Baxter faces a number of lawsuits over a heparin recall issued in January 2008, involving defective batches of the blood thinner that are believed to have killed 81 people and sickened hundreds more in late 2007 and early 2008.

The Baxter heparin recall was issued after a spike in adverse event reports surfaced involving reactions to heparin, an anticoagulant or blood thinner that is critical for a number of medical procedures and conditions. The lawsuits are currently consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, in the U.S. District Court for the Northern District of Ohio. All of the cases involve similar allegations that tainted lots of heparin distributed by Baxter Healthcare caused severe and potentially life-threatening allergic-type reactions.

At that time, Baxter manufactured about half of the injectable heparin sold in the United States and it was discovered that the blood thinner contained a fake ingredient received from a plant in China that was chemically similar to heparin, yet substantially cheaper.

Investigations by the FDA and a report published in the New England Journal of Medicine in December 2008 found that the heparin reactions were caused by the presence of oversulfated chondroitin sulfate. FDA investigators and researchers believe the fake ingredient was used for fraudulent purposes, to save money.