FDA: Baxter Recalling Hyaluronidase Human Injection
Product recalled after glass particles found in vials during stability testing
THURSDAY, May 27 (HealthDay News) -- Baxter International Inc. has announced a voluntary recall of hyaluronidase human injection (Hylenex recombinant), as particulate matter was found in a limited number of vials during standard stability testing.
Hyaluronidase human injection is a tissue permeability modifier used to increase the dispersion and absorption of other injected drugs and to improve resorption of radiopaque agents, as well as for achieving hydration in administration of subcutaneous fluid. The voluntary recall was issued as a precautionary measure because some vials of the drug were found to contain small glass particles.
To date, no adverse events linked to this issue have been reported. Approximately 3,500 vials of the drug are estimated to be in the marketplace, and the company is contacting customers to request the drug be returned to the company. The root cause of the issue has yet to be determined.
"Baxter is working with the product's new drug application-holder, Halozyme Therapeutics, to investigate the root cause of the issue and appropriately address the situation," according to the FDA's safety alert.