May 18, 2010 (FinancialWire) — Halozyme Therapeutics, Inc. (NASDAQ: HALO) said that it and Baxter (NYSE: BAX) 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. On May 17, Halozyme said it notified the U.S. Food and Drug Administration that it is voluntarily recalling affected lots of 150U HYLENEX product from distribution.  

According to Baxter, the recall affects around 3,500 vials in the distribution chain. The companies said the action is being taken as a precautionary measure in order to ensure patient safety. They stressed that 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.

Hylenex, which has been approved by the FDA for subcutaneous fluid administration, works by temporarily making the tissue beneath the skin more permeable and able to absorb fluid, allowing fluids to be more readily absorbed into the blood vessels.

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

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