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Heparin recalled in France, Italy, Denmark: report
Mar 26, 08 Medical Product Safety AlertsSupplies of the blood-thinning drug heparin are being recalled in France, Italy and Denmark because they are contaminated or suspected of being contaminated, although there have been no reports of patients being harmed by the drug in those countries, the Wall Street Journal said.
The European Medicines Agency presumes the contaminant in all three countries is the same as the one identified in recalled U.S. batches of the drug, a chemical called over-sulfated chondroitin sulfate, the article on the Journal’s web site said.
France on Friday began recalling heparin made by Rotexmedica GmbH, the same company that made heparin which was recalled from Germany earlier this month, the article said, citing a spokesman for the European regulator.
Moreover, the active ingredient used to make heparin is being recalled in Italy and Denmark because it is contaminated, the agency spokesman said. The chemical was made by an Italian company, Opocrin SpA, which used raw ingredients sourced in China, the agency spokesman said.
Batches of the drug have recently been recalled in Germany and the United States, where some patients taking the drug suffered allergic reactions. In both the United States and Germany, the contamination surfaced in supplies made from ingredients bought in China, the article said.
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