Halozyme Therapeutics, Inc 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, Halozyme notified the US Food and Drug Administration 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.

Hylenx, approved by the FDA for subcutaneous fluid administration, works by temporarily making the tissue beneath the skin more permeable (capable of being passed through) and able to absorb fluid, allowing fluids to be more readily absorbed into the blood vessels.

Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets.