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TGA recalls four more batches of Clexane

This article was originally published in Scrip

Executive Summary

Australia's Therapeutic Goods Administration (TGA) has recalled four more batches ofSanofi-Aventis’s anticoagulant Clexane (enoxaparin), following detection of over-sulphated chondroitin sulphate (OCSC). Recalled doses include three batches of Clexane 8mg – batch numbers 08012, 08012A and 08014 – and one batch of Clexane 100mg, batch number 01010. The recall follows seven previous batches also recalled earlier this year. Patients prescribed Clexane are advised to check with their doctor or pharmacist that their supply is not affected by the recall. Appropriate alternative anticoagulants for prescription include Fragmin (dalteparin sodium), unfractionated heparin or oral anticoagulants. OCSC has been associated with severe adverse reactions in the US and Europe; to date, there have been no reports in Australia.

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