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Home » Drugs, FDA, Prevention, Recalls

China Behind Japanese Recall of US-Made Heparin

Submitted by admin on March 11, 2008 – 9:27 pm2 Comments
 

Three Japanese companies recently recalled the drug, heparin, because its manufacturer in Wisconsin uses ingredients from China. They cite precaution as their reason for the recall. Scientific Protein Laboratories in Waunakee, Wisconsin, gets its product from its own plant in China. It also provides the active ingredient in heparin to Baxter International Inc., in Deerfield. Last month, the Scientific Protein plant in China was forced to close after hundreds of people in the US reported life-threatening allergic reactions, at least four of which resulted in death, to the heparin linked to the China source.

A similar outbreak of allergic reactions to heparin, with a supply link to China, occurred recently in Germany. The supplier of the German heparin, Rotexmedica, purchased the drug from a supplier other than Scientific Protein.

The allergic reactions include low blood pressure and racing heartbeats. Both the US Food and Drug Administration (FDA) and Scientific Protein decline to reveal the names of the three companies in Japan recalling the heparin. While no adverse reactions have been documented in Japan, the three companies describe the recall as a simple precautionary measure.

The FDA reports a “heparin-like” substance found in the recalled heparin from Baxter International and suggests the drug’s active ingredient may have been tampered with during Chinese production or in the pre-factory supply chain in China.

Heparin’s active ingredient gets its start in rural China, on pig farms. The ingredient is then processed in unregulated family workshops in local villages before delivery to the Changzhou factory owned by Scientific Protein.

The FDA investigation of Baxter International’s heparin supply remains ongoing and the “heparin-like” foreign substance has yet to be identified.

2 Comments »

  • Dr. Dave says:

    I just don’t get it. How much money do these companies save by purchasing animal based drugs from China? Don’t we have enough pigs in America slaughtered and regulated by government agencies? We don’t have a perfect system but still, it beats rural mom & pop animal chop shops in China where hygiene is the last thing on peoples minds.

    WE ALL know that China “knocks off” everything from Prada handbags & Rolex watches to CDs & DVDs. They are truly masters of illusion when it comes to products. They even go so far as to knock off UL labels and put them on faulty extension cords used extensively during Christmas.

    Manufacturing companies in communist China are under tight & complete government approval like financing, land sales & “ownership” selection. It seems the government has no qualms about pirating, polluting or tainting any product so long as it makes money. I can understand the chaep products we love to buy at Wal-Mart but I am shocked at how many products that get ingested into the human body originate from China. Even sucking candy!

    Personally I would never intentionally ingest any of these products and I think until China cleans up it’s act, America should ban them from being sold here. The Europeans and Americans have established standards that will take generations for China to achieve.

  • Mr. Strong says:

    This is a country and culture with a history over the last ten years of substituting counterfeit products for safe ones, even when the counterfeit one is dangerous or deadly.

    Not just for export, there have been cases of pesticides being used to preserve foods, and salts marked “not for human use” being used in foods because of a price difference of a couple dollars per ton. Who knows how many innocent Chinese citizens have been killed by this profiteering?

    It’s crazy for US companies to import any ingredients from China.

    Why do they do it? For the same reason the Chinese make fake drugs, to save money. In order to get that lower price point for the insurance company or Wal-Mart.

    I won’t buy any food product made in China, but I worry about where my last dose of Heparin originated.

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