Halozyme Therapeutics is recalling its fluid absorption drug Hylenex and is pointing the finger of blame at manufacturing partner Baxter. Test vials were found to be contaminated with flakes of glass, a Baxter release states. The recall affects about 3,500 vials now in the distribution chain.
Before the recall was announced, Halozyme had said that Baxter exhibited "manufacturing failures" in making the drug, which it produces under license. Halozyme says it notified Baxter that it had breached the Hylenex development and supply contracts. "[C]ertain materials produced by Baxter are not in compliance with the requirements of the Hylenex agreements," Halozyme says in a statement.
If Baxter doesn't fix the manufacturing problems within 120 days, Halozyme says it might yank the license. It also said that it's working with the FDA and Baxter on the problems; the recall is a precautionary measure, it adds.
- see the Baxter press release
- read the statement from Halozyme
- get the Reuters news