13 06 2008:  MediCult products not affected by Heparin recalls

To whom it may concern

The US Food and Drug Administration (FDA) has earlier this year reported that a chemical contaminant had been found in certain batches of Heparin, resulting in serious patient contaminations and product recalls by Baxter International and Rotexmedica GmbH.

MediCult a/s products SynVitro Flush with Heparin (1576) and Flushing Medium with Heparin (1076) both contain Heparin 5000 produced by LEO Pharma A/S.

LEO Pharma A/S has never used the suppliers affected by the Baxter and Rotexmedica recalls.

Since the alert, LEO Pharma A/S has tested all their Heparin substances according to the two analytical methods published by FDA (H-NMR and CE). This ensures that any presence of the contaminant would be detected.

Regards,

Tove Kjær
Regulatory Affairs manager

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