Heparin Recall - Now Link to China

Heparin Practice Center:
__________________

Serratia Marcescens

Sierra Heparin Lock Flush

Heparin Recall - Now Link to China

The Baxter Heparin Recall

We will work under a Contingency Fee Contract
Did you know that the China State Food and Drug Administration is now investigating the case of recalled Baxter's Heparin and attempting to determine if pharmaceutical or non-pharmaceutical ingredients were used or introduced into this drug. Heparin is the number one blood thinner drug used worldwide for kidney dialysis and surgeries. The Baxter Heparin was recalled in early February because of four deaths and numerous serious allergic reaction. Since that time more than 20 deaths have been linked to this recall. The recall has caused some panic among health professionals and officials, because they have no alternative they can use instead of heparin.

The China SFDA and the United States FDA are now cooperating to determine the cause of the problem and inspect the factory producing the heparin. An agreement in late 2007 between Washington and Beijing put high responsibilities on food and drug safety to calm the scandals down around tainted or substandard products. FDA announced significant improvement after the agreement signed. However, this heparin case posed even more scandals, and the administration is doing the best to find out the reason of why the product lacks safety. According to FDA announcement, they "are conducting inspections at a Baxter facility in New Jersey, at company supplier Scientific Protein Laboratories of Wisconsin and at Changzhou SPL, a factory in the eastern Chinese city of Changzhou that is 55 percent owned by Scientific Protein Laboratories." China SFDA is also checking the factory, but they have not released any details about the investigation.

It is believed that Changzhou SPL was never inspected by the FDA.  It should also be noted that, the factory is registered in China as a chemicals manufacturer and not  registered as a pharmaceutical manufacturing plant. 





































TRADEMARK NOTICE:
Heparin Lock Flush and Baxter Heparin are trademarks of Sierra, Inc. and Baxter International Inc. accordingly.

The Carabin & Shaw Law Firm, its' lawyers and this website is in no way affiliated with Sierra, Inc. and Baxter International Inc. The use of this mark is solely for informational and product identification purposes.