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Contaminated heparin became a serious concern in the U.S. and around the world when Baxter International announced a mass recall in February 2008. Batches of contaminated heparin made with ingredients from China were recalled in the United States, and the same type of contaminated heparin was identified in 10 other countries. The contaminated Baxter heparin products have been linked to more than 80 deaths in the U.S. alone.

From Pigs Raised in China

Heparin is made from mucosal tissues such as pig intestine and cow lung. The contaminated heparin at the heart of the recall was made from the intestines of pigs raised on farms in China, and the farming and quality control standards were clearly not adequate.

A Cheap, Synthesized Contaminant

The contaminant in the Baxter heparin is oversulfated chondroitin sulfate (OSCS), a derivative of a supplement used to relieve arthritis ¾ chondroitin sulfate. OSCS is an unusual form of chondroitin sulfate, not found in any natural sources of chondroitin sulfate. OSCS cannot be obtained or derived from biological sources; it’s synthetic. It also costs $9 a pound, whereas heparin costs $900 a pound.

Problems in the Supply Chain

The American company that got the contaminated heparin from its China sources, Scientific Protein Laboratories (SPL), supplied the heparin to Baxter. The chief executive of SPL, David Strunce, said that his company tried to find the source of the contamination in China but was stopped by the Chinese authorities.

According to an April 2008 article in The New York Times, the U.S. Food and Drug Administration (FDA) suspects that the contamination was intended, not accidental. The director of the FDA, Dr. Janet Woodcock, told the House Subcommittee on Oversight and Investigations on April 29 that “the FDA’s working hypothesis is that this was intentional contamination, but this is not yet proven.”

Learn More about Contaminated Heparin

Thousands of people have been harmed by contaminated heparin or other drugs. Contact an experienced attorney to find out more.

"Heparin Linked Deaths Continue to Pile"

After months of investigation, the U.S. Food and Drug Administration has definitively tied three patient deaths to contaminated heparin.

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"Devices Coated with Carmeda BioActive Recalled"

Medical device maker Medtronic has issued a voluntary recall of heparin-coated bypass equipment, including pumps, reservoirs and blood oxygenators. The company said the recall is a pre...

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"Families Testify for Loved Ones Harmed by Heparin"

The families of people who died from contaminated heparin injections testified before Congress last week, expressing anger and grief over manufacturing and regulatory safety failures.

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