Baxter’s Heparin Ingredients Supplied By Unlicensed Chinese Company
This article was originally published in PharmAsia News
Executive Summary
The active pharmaceutical ingredient in Baxter Internationals' blood thinner Heparin (heparin sodium) came from a factory in Changzhou, China, that had not been certified by China's State FDA. As a result, neither Chinese nor U.S. authorities had inspected the Changzhou Scientific Protein Laboratories plant where the API was made from pig intestines. The cause of four deaths and complications reported by 350 patients has not been determined. A Baxter spokeswoman said her company had inspected the plant on its own volition less than six months ago, but the U.S. supplier acknowledged the Changzhou plant had not been licensed by the SFDA. Scientific Protein did say the raw materials used had come from a licensed plant. (Click here for more