Baxter recalls Hylenex due to presence of particulate matter

Baxter announced a voluntary recall of all lots of Hylenex recombinant (hyaluronidase human injection) as a precautionary measure due to instances of particulate matter observed in a limited number of Hylenex vials during routine stability testing. Baxter is working with Hylenex’s NDA-holder, Halozyme Therapeutics, to investigate the root cause of the issue and appropriately address the situation.

HYLENEX recombinant is a tissue permeability modifier indicated as an adjuvant in subcutaneous fluid administration for achieving hydration; to increase the dispersion and absorption of other injected drugs; and in subcutaneous urography for improving resorption of radiopaque agents.

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