San Diego, CA—Baxter International Inc., the maker of a fluid absorption drug, is being accused of having “manufacturing failures.” The biopharmaceutical company, Halozyme Therapeutics, stated on Sunday, May 16, 2010, that they may stop using the fluid absorption drug, Hylenex, if the maker doesn’t come into compliance, as reported by Reuters.
Even though no medical events have occurred in connection with the “noncompliant” Hylenex, Halozyme sent a notice of breach to Baxter. The letter stated that Baxter has failed to provide the drug in accordance with the terms of their development and supply contracts. Halozyme also stated that they had “concerns over the quality and capabilities of Baxter’s manufacturing operations.”
Halozyme believes that the manufacturing problems are only related to the “150U Hylenex” product.
If Baxter is unable to rectify the material breaches within 120 days, Halozyme will likely end their relationship with Hylenex.
Halozyme says they are working with both Baxter and the U.S. Food and Drug Administration (FDA) to ensure the safety of the product. They are also investigating the causes and effects to the manufacturing problems.
Legal News Reporter: Nicole Howley-Legal news for California product liability attorneys.