Sanofi Aventis Australia Pty Ltd—Clexane enoxaparin sodium
What are the defects?
Certain batches have been found to contain measurable levels of the impurity over-sulphated chondroitin. The presence of over sulphated chondroitin in pure heparin has been associated with the occurrence of anaphylactic reactions in the US and Germany. It has been established than an additional batch of Clexane 80mg/0.8mL previously released to the Australian market also contains the impurity, over-sulphated chondroitin sulphate. It has been established that this additional batch of Clexane 120mg/0.8mL previously released to the Australian market also contains the impurity, over-sulphated chondroitin sulphate. The recall is being implemented as a precautionary measure as these batches of Clexane have been manufactured from heparin containing low levels of an impurity, over sulphated chondroitin sulphate (OSCS).The presence of OSCS in pure heparin has been associated with the occurrence of anaphylactic reactions in the US and Germany. However to date there continues to be no increase in reports of anaphylactic reactions in patients receiving Clexane in Australia.
What are the hazards?
Illness or mistreatment (Class II).
What should consumers do?
Therapeutic Goods Administration is the responsible regulator for this recall.