FDA批准重组人类透明质酸酶注射剂（Recombinant Human Hyaluronidase Injection，商品名Hylenex）作为其他注射药物的辅助药物（促进吸收和扩散），用于皮下注射以及皮下尿路造影术中促进不透射线物质的吸收。

Pharmaceutical Liability News: Baxter notifies FDA of HYLENEX recombinant recall

Deerfield, IL—Baxter International Inc., in cooperation with the U.S. Food and Drug Administration (FDA), announced the voluntary recall of all lots of HYLENEX recombinant (hyaluronidase human injection). The FDA announced the recall, which was issued in conjunction with the product’s NDA-holder, Halozyme Therapeutics, on Monday, May 17, 2010.

Baxter International and Halozyme Therapeutics recalled the drug after routine stability tests revealed the presence of particulate matter in a limited number of HYLENEX vials. The particles found in these lots were identified as glass.

Baxter reported there are approximately 3,500 vials in the market place. The company will be contacting consumers to inform them of the recall and advise them to return the defective product.

The 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.”

Though Baxter has received no reports of adverse medical episodes in association with the product, the recall was issued as a safety precaution.

Baxter and Halozyme are working together to probe what might have caused the problem. According to the FDA press release, “Baxter and Halozyme are committed to quickly and appropriately addressing the situation.”