Scientific Protein Laboratories Statement Regarding Heparin Recall In Japan

Main Category: Pharma Industry / Biotech Industry
Article Date: 12 Mar 2008 - 2:00 PDT

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We have learned that, as a precaution, three Japanese companies have recalled heparin whose active pharmaceutical ingredient (API) was sourced in China and processed by SPL. The three Japanese companies made clear that the recall was simply a precaution, as there has not been a pattern of adverse reactions to heparin reported in Japan similar to what has been observed in the U.S. and Germany. We also understand that testing of the active pharmaceutical ingredient (API) used to make the products in Japan did not have any "peaks" as has been seen in certain lots of heparin recalled by Baxter in the U.S.

It is important to note that the heparin recalled in Germany was in no way associated with API from either SPL or Changzhou SPL, and that the root cause of the adverse reactions is still being investigated aggressively by the Food and Drug Administration, German health authorities, Baxter, SPL and others. SPL heparin API sourced from North America has not been implicated in the recent recalls and tests to date have not identified any unexplained peaks in North American-sourced materials.

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