On Monday Baxter International recalled lots of its Hylenex (hyaluronidase human injection) recombinant less than a year after release, because of small, flake-like glass particles found in vials of the product during routine stability testing. Baxter, which makes Hylenex for Halozyme Therapeutics Inc., said the recall is voluntary and that to date, no medical events or customer complaints have been reported.
According to Halozyme's website, "Hylenex is a human recombinant formulation of rHuPH20 to facilitate the absorption and dispersion of other injected drugs or fluids. When injected under the skin or in the muscle, hyaluronidase can digest the hyaluronic acid gel, allowing for temporarily enhanced penetration and dispersion of other injected drugs or fluids." The drug was launched in the United States in 2009 for use in pediatric and infant intravenous rehydration.
The Food and Drug Administration (FDA) has been notified of the problem, and Baxter is now contacting customers to request return of the product. According to Baxter, this affects approximately 3,500 vials. Halozyme said neither the rHuPH20 bulk enzyme nor other products containing that enzyme were affected.
In a letter delivered to Baxter, Halozyme Inc. states that "Baxter is in breach due to failure to provide its Hylenex per the firm's development and supply contracts." Halozyme said the statement came after Baxter told the firm that certain materials produced by Baxter for the firm did not meet requirements of agreements. Also, if Baxter is not able to fix the issues within 120 days, it may terminate its relationship with Baxter. Halozyme also said it is working with Baxter and the FDA to investigate the cause and extent of the manufacturing issues.