FDA Finds 14 Additional Chinese Companies That Supplied Contaminated Raw Materials Used to Make Heparin And Puts Out Alert ̵
Posted Feb 22 2012 5:45pm
We all remember the Baxter incident from a few years ago. The FDA has put out a warning list with additional companies listed and they did not know or state if they were current distributors of the raw material that makes the blood thinning drug. Back in October of 2010 it was back in the news again with another recall.
We need more home grown pigs intestines from the US is appears as that is one of the raw materials that goes into the drug. BD
The Food and Drug Administration said Wednesday it found 14 additional Chinese companies supplied contaminated raw material to make heparin, a widely used blood thinner.
The companies supplied the materials in 2008, when the FDA found a link between contaminated heparin marketed by Baxter International Inc. to some Chinese suppliers of the active ingredient used in heparin. The contamination was linked to 80 deaths in U.S. patients and hundreds of allergic reactions. The same contamination was found in heparin sold by other pharmaceutical companies in other countries.
The 14 companies were put on a so-called import alert list that allows the FDA to stop shipments at the U.S. border. The companies are being added to a list that already included eight other Chinese suppliers.
The contaminated heparin contained oversulfated chondroitin sulfate, an altered version of chondroitin sulfate that is used as a dietary supplement and is typically made from animal cartilage. Oversulfated chondroitin sulfate is chemically similar to the active ingredient in heparin, which is derived from pig intestines. Federal health officials have said it is cheaper to make than the active ingredient in heparin. It still remains unknown how the heparin became contaminated and who might be responsible, although FDA is still investigating.