3 Japanese Firms Recall Heparin
March 11, 2008
No ill effects reported; action 'precautionary'
Bruce Japsen
www.chicagotribune.com
In a blow to a Wisconsin-based maker of the blood thinner heparin's active ingredient, three Japanese companies recalled the product as a "precautionary step" because of worries about its link to Chinese manufacturing, the Food and Drug Administration said Monday.
There have been no adverse events reported in Japan from patients who used heparin produced by Scientific Protein Laboratories of Waunakee, Wis., and sourced from China.
Neither the FDA nor Scientific Protein would disclose the names of the three Japanese companies. Scientific Protein also provided Deerfield-based Baxter International Inc. with heparin's active ingredient before Scientific Protein's plant in China was shuttered last month amid an investigation into hundreds of life-threatening allergic reactions and at least four deaths.
"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," Scientific Protein said in a statement Monday.
"We also understand that testing of the active pharmaceutical ingredient 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."
Allergic reactions, which include racing heartbeats and low blood pressure, also have been linked to China-sourced heparin ingredients in Germany. A cause of the allergic reactions in Germany has yet to be determined. The supplier of the product to Rotexmedica, the company that sold it, was not Scientific Protein.
In the U.S., FDA officials said a foreign "heparin-like" substance was found in recalled batches of heparin sold by Baxter. The FDA said heparin's active ingredient might have been tampered with during production in China at Scientific Protein's factory or in the supply chain leading up to the factory.
The supply chain, which starts with pigs in farm lots in rural China, runs through unregulated family workshops and villages before reaching Scientific Protein's Changzhou factory. The FDA said Monday that it has yet to determine what the foreign substance in Baxter's version of heparin is. The FDA's investigation and testing of batches of heparin recalled by Baxter continues, the agency said.
No ill effects reported; action 'precautionary'
Bruce Japsen
www.chicagotribune.com
In a blow to a Wisconsin-based maker of the blood thinner heparin's active ingredient, three Japanese companies recalled the product as a "precautionary step" because of worries about its link to Chinese manufacturing, the Food and Drug Administration said Monday.
There have been no adverse events reported in Japan from patients who used heparin produced by Scientific Protein Laboratories of Waunakee, Wis., and sourced from China.
Neither the FDA nor Scientific Protein would disclose the names of the three Japanese companies. Scientific Protein also provided Deerfield-based Baxter International Inc. with heparin's active ingredient before Scientific Protein's plant in China was shuttered last month amid an investigation into hundreds of life-threatening allergic reactions and at least four deaths.
"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," Scientific Protein said in a statement Monday.
"We also understand that testing of the active pharmaceutical ingredient 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."
Allergic reactions, which include racing heartbeats and low blood pressure, also have been linked to China-sourced heparin ingredients in Germany. A cause of the allergic reactions in Germany has yet to be determined. The supplier of the product to Rotexmedica, the company that sold it, was not Scientific Protein.
In the U.S., FDA officials said a foreign "heparin-like" substance was found in recalled batches of heparin sold by Baxter. The FDA said heparin's active ingredient might have been tampered with during production in China at Scientific Protein's factory or in the supply chain leading up to the factory.
The supply chain, which starts with pigs in farm lots in rural China, runs through unregulated family workshops and villages before reaching Scientific Protein's Changzhou factory. The FDA said Monday that it has yet to determine what the foreign substance in Baxter's version of heparin is. The FDA's investigation and testing of batches of heparin recalled by Baxter continues, the agency said.