Glass Flakes in Vials Prompt Halozyme, Baxter to Recall Hylenex Pediatric Rehydration Product

First San Diego’s Cadence Pharmaceuticals (NASDAQ: [[ticker:CADX]]), and now, Halozyme Therapeutics (NASDAQ: [[ticker:HALO]]), have encountered troubles resulting from contaminated biomedical products coming from their manufacturing partner, Baxter Healthcare, a unit of Baxter International (NYSE: [[ticker: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.

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.