An alternative treatment for dehydration in pediatric patients is being recalled by the manufacturer because some lots of the product were found to be contaminated, the Food and Drug Administration (FDA) reports. Baxter International Inc., says it initiated the voluntary recall on all manufactured lots of HYLENEX recombinant (hyaluronidase human injection) as a precautionary measure after routine stabilization testing found particulate matter in some vials. The particulate matter consisted of small, flake-like particles identified as glass. About 3,500 vials are included in the recall.

HYLENEX recombinant is used to hydrate patients, increase the dispersion and absorption of other injected drugs, and in subcutaneous urography for improving re-sorption or radiopaque agents. In October 2009, the product was launched in the United States for use in pediatric re-hydration.

Baxter licenses the HYLENEX recombinant technology from Halozyme, which discovered and completed development work to secure FDA approval. Baxter has worldwide exclusive rights to market and sell HYLENEX recombinant. Baxter is working with the product’s NDA-holder, Halozyme Therapeutics, to investigate the root cause of the issue and to appropriately address the situation.

To date, no medical events or consumer complaints associated with this issue have been reported. However, any adverse events associated with this or any other medical product should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.