The Pharmaceutical Journal
Vol 280 No 7502 p588
17 May 2008

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Avoid parallel-imported Clexane

Some packs of Clexane (enoxaparin sodium) prefilled syringes supplied to overseas markets have higher levels of the contaminant over-sulphated chondroitin sulphate (OSCS) than is considered acceptable by the Commission on Human Medicines. The Medicines and Healthcare products Regulatory Agency does not want to see these batches supplied to the UK as parallel imports.

Last month the MHRA issued a Class 4 drug alert about Clexane (PJ, 3 May 2008, p529) but stated that batches contaminated with levels of OSCS below 5 per cent could continue to be supplied.

This advice still stands but the MHRA is now advising parallel importers not to distribute certain batches of Clexane prefilled syringes (as well as Lovenox-branded enoxaparin products) within the UK and reminding potential recipients of these batches that parallel importers may modify the originator’s batch number by adding a prefix or suffix or by using their own number.

It advises recipients to contact the parallel importer for clarification if they have any concerns.

The relevant batch numbers can be found on the MHRA website