
FRANKFURT, March 7 (Reuters) - Germany has ordered a countrywide recall of blood-thinner heparin, made by Rotexmedica, on fears of contamination, a German health official said, confirming comments by the U.S. Food and Drug Administration (FDA).
"There is suspicion that batches of heparin produced by Rotexmedica have been contaminated," said Ulrich Hagemann, a department chief at the Federal Institute for Drugs and Medical Devices, which has coordinated the recall with the healthcare department of the German state of Schleswig-Holstein.
Hagemann said the drug could be using active ingredients from China, adding that three severe cases of allergic reaction had been reported so far.
Rotexmedica, a unit of French company Panpharma, was not immediately available for comment.
Heparin is derived from pig intestines and is used in dialysis and heart procedures, among other surgeries, to avoid blood clots.
The recall brings into question the safety of European supplies of the drug, which became the target of a U.S. investigation after a spike in fatalities and severe reactions in some patients taking heparin sold by Baxter International Inc (BAX.N).
The FDA began probing Baxter's heparin several weeks ago after it was linked to four deaths and hundreds of severe reactions, such as breathing problems and rapid drops in blood pressure. On Wednesday it said it identified a contaminant that may be linked with the drug's problems.
Some 19 fatalities have now been associated with use of the drug in the United States, the FDA said on Wednesday. However, none of the deaths have been linked to a specific drug maker. (Reporting by Frank Siebelt, Mantik Kusjanto, editing by Will Waterman)