By Bruce Japsen | Medical product giant Baxter International Inc. and a San Diego biotech
company issued a voluntary recall of Hylenex vials after discovering
small “flake-like glass particles in a limited number of vials.”  

The recall comes less than a year after Baxter launched the product as
a new way to administer intravenous fluids to rehydrate children and
infants more quickly and efficiently. Hylenex can be administered
without the tricky search for a tiny vein.

The conventional method requires health care professionals to find a
vein, typically in the child’s arm. That sometimes can take multiple
attempts because of a squirming child or the small size of the veins,
health care professionals say.

Baxter and partner Halozyme Therapeutics Inc. said the recall of Hylenex is being initiated “as a precautionary measure due to instances of particulate matter observed in a limited number of Hylenex vials during routine stability testing,” the company said. The testing occurred in products that were already on the U.S. market.  

So far, the companies said there have been “no medical events or customer complaints associated with this issue.”  The companies also said the U.S. Food and Drug Administration has been notified and Baxter, which is responsible for distributing Hylenex, said it will be notifying customers to request they return the product.

Baxter said there are about 3,500 vials on the U.S. market in the distribution chain. It said it provided Halozyme with fill and finish services in the manufacture of the product.