The source of contaminants found in a German version of the blood-thinning drug heparin has been narrowed down to one possible supplier from China, manufacturer RotexMedica GmbH said Friday.
The Trittau, Germany-based company, part of France's Groupe Panpharma, recalled three batches of the drug last week after 80 dialysis patients were sickened, saying at the time that the contamination was believed to be linked to ingredients from China.
In a statement Friday, RotexMedica said that its investigation has now narrowed down the source of contamination to one possible supplier from China. The statement did not identify the company, and a spokeswoman would not elaborate.
"Further investigation is still necessary to confirm this finding," the company said.
While there have been no reported fatalities in Germany, a different brand of heparin produced in the U.S. has been linked to 19 deaths there, according to the U.S. Food and Drug Administration.
The FDA urged all U.S. suppliers of heparin to start using high-tech tests to make sure their products are free of a contaminant that is the prime suspect for hundreds of allergic-type reactions linked to Baxter International Inc.'s U.S.-sold heparin injections.
RotexMedica said it was working with German authorities, the FDA, and German and international heparin suppliers as part of a large study of the drug.
"As soon as there are more findings, RotexMedica will further inform the public," the company said.
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