Hylenex recombinant (hyaluronidase human injection): Recall
Audience: Risk Manager, Emergency Medicine
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.
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our Newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.