Glass Flakes in Vials Prompt Halozyme, Baxter to Recall Hylenex Pediatric Rehydration Product
First San Diego’s Cadence Pharmaceuticals (NASDAQ: CADX), and now, Halozyme Therapeutics (NASDAQ: HALO), have encountered troubles resulting from contaminated biomedical products coming from their manufacturing partner, Baxter Healthcare, a unit of Baxter International (NYSE: BAX) of Deerfield, IL.
Today Halozyme and Baxter said they are voluntarily recalling affected lots of a product called Hylenex that is used to treat pediatric dehydration after discovering glass flakes in “a limited number of vials.”
In a statement, Halozyme says no “medical events” associated with glass particles in vials of Hylenex have been reported, and the recall is being taken as a precautionary measure to ensure patient safety. Baxter says the contamination affects some 3,500 vials in distribution.
As Denise reported in February, Cadence suffered a setback in its efforts to win FDA approval for its intravenous form of acetaminophen (the pain reliever used in Tylenol and other products) after an FDA inspection identified numerous deficiencies in a Baxter plant in Cleveland, MS, that was preparing to manufacture the product. After meeting with the FDA in April, and resubmitting its filing for a new drug application for its IV painkiller, called Ofirmev, the FDA said it would act on Nov. 4, according to Cadence.
Halozyme said earlier today it had notified Baxter Health that it had breached the terms of its supply contract. Halozyme said if Baxter is unable to address the contamination issue within 120 days, it may terminate the contract.