Product description
Clexane enoxaparin sodium 20mg/0.2mL injection syringe, AUSTR 42965, Batch No 02115, Expiry Date 10/2010; Clexane enoxaparin sodium 40mg/0.4mL injection syringe, AUST R 42962, Batch No 04526, Expiry Date 10/2010; Clexane enoxaparin sodium 80mg/0.8mL injection syringe, AUST R 56710, Batch No 08009, Expiry Date 05/2010; Clexane enoxaparin sodium 100mg/1.0mL injection syringe, AUST R 56711, Batch No 01011, Expiry Date 10/2010; Clexane enoxaparin sodium 100mg/1.0mL injection syringe, AUST R 56711, Batch No 01007, Expiry Date 06/2010; Clexane enoxaparin sodium 80mg/0.8mL injection syringe, AUST R 56710, Batch No. 08018, Expiry Date 11/2010. AUST R 74173, Batch No. 12155, Expiry Date 08/2009. Clexane (enoxaparin sodium) 80 mg/0.8mL injection syringe. AUST R 56710. Batch No. 08012. Expiry Date 09/2010. Dates Distributed 23/11/2007. Clexane (enoxaparin sodium) 80 mg/0.8mL injection syringe. AUST R 56710. Batch No. 08012A. Expiry Date 09/2010. Dates Distributed 11/03/2008. Clexane (enoxaparin sodium) 80 mg/0.8mL injection syringe. AUST R 56710. Batch No. 08014. Expiry Date 09/2010. Dates Distributed 18/03/2008. Clexane (enoxaparin sodium) 100 mg/1.0mL injection syringe. AUST R 56711. Batch No. 01010. Expiry Date 10/2010. Dates Distributed 26/03/2008.
See a list of details to help identify the product
Reason the product is recalled
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.
The hazards to consumers
Illness or mistreatment (Class II).
What consumers should do
N/A
Details to help identify the product
Supplier running the recall
Sanofi Aventis Australia Pty Ltd
Identifying product features
See above
Identifying numbers
Other identifying numbers
See above
Where the product was sold
Nationally
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2008/9979 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.