Baxter International Inc. announced a voluntary recall of all manufactured lots of Hylenex recombinant (hyaluronidase human injection) has been initiated as a precautionary measure due to instances of particulate matter observed in a limited number of vials during routine stability testing. To date, no medical events or customer complaints associated with this issue have been reported. As part of this stability testing for Hylenex recombinant, a limited number of vials were observed to contain small, flake-like particles, identified as glass. The company estimates that there are approximately 3,500 vials in the marketplace.
Baxter is working with the product's NDA-holder, Halozyme Therapeutics, to investigate the root cause of the issue and appropriately address the situation.
[05/17/2010- Firm Press Release- Baxter International Inc.]