China Behind Japanese Recall of US-Made Heparin
March 11, 2008
www.medheadlines.com
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.
www.medheadlines.com
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.