Halozyme Therapeutics, Inc. today announced that Halozyme and Baxter have confirmed the presence of small flake-like glass particles in a limited number of vials of HYLENEX (hyaluronidase human injection) product at the Baxter manufacturing facility. Earlier today, Halozyme notified the FDA that it is voluntarily recalling affected lots of 150U HYLENEX product from distribution. According to Baxter, this affects approximately 3,500 vials in the distribution chain. This action is being taken as a precautionary measure in order to ensure patient safety. No medical events associated with the noncompliant HYLENEX product have been reported.
Halozyme’s clinical assessment is that the health risk posed by the noncompliant HYLENEX product is low. Neither the rHuPH20 bulk enzyme nor any other products containing the enzyme are believed to be affected.