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Typhim Vi® (Vi polysaccharide typhoid vaccine) Vaccine Recall

08 October 2012

Sanofi Pasteur MSD is recalling the 16 batches of Typhim Vi® (Vi polysaccharide typhoid vaccine) listed below following a recent investigation that indicated some syringes may potentially have antigen levels below the required specification. This means that some individuals who have been vaccinated with Typhim Vi since 07 January 2011, may be insufficiently protected against typhoid.

All travellers should, in any case, be advised of the importance of exercising scrupulous food and water hygiene precautions when visiting areas where typhoid is prevalent.

Not all doses in these batches are affected but it is not possible to predict who may have received the affected doses. It is understood that there are no additional safety concerns associated with affected batches.

The recall will result in this product being out of stock by the end of October so revaccination is not practical. At this time, Sanofi Pasteur MSD is unable to confirm when normal supply of the vaccine will resume.

Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit.

For enquiries relating to stock returns please contact Sanofi Pasteur MSD Customer Services on 0800 0855511 or by fax on 08000858958

For medical information enquiries, please telephone 0800 7311654 or fax to 01628 635072.

Typhim Vi batches being recalled:

Batch Number Expiry date Pack size Date of first distribution
G0069-1 31 Jan 2013 1 x 0.5ml pre-filled syringe 07/03/2011
G0069-2 31 Jan 2013 10 x 0.5ml pre-filled syringe 07/01/2011
G0069-3 31 Jan 2013 10 x 0.5ml pre-filled syringe 08/02/2011
G0327-3 30 Jun 2013 1 x 0.5ml pre-filled syringe 11/04/2011
G0327-4 30 Jun 2013 10 x 0.5ml pre-filled syringe 28/04/2011
G0529-2 30 Sep 2013 1 x 0.5ml pre-filled syringe 19/06/2012
G0530-1 30 Sep 2013 10 x 0.5ml pre-filled syringe 28/03/2012
G0563-1 30 Sep 2013 10 x 0.5ml pre-filled syringe 21/07/2011
G0574-1 31 Oct 2013 10 x 0.5ml pre-filled syringe 03/08/2011
G0574-6 31 Oct 2013 10 x 0.5ml pre-filled syringe 18/10/2011
H0048-1 31 Jan 2014 1 x 0.5ml pre-filled syringe 04/10/2011
H0048-6 31 Jan 2014 1 x 0.5ml pre-filled syringe 01/12/2011
H0473-1 30 Sep 2014 10 x 0.5ml pre-filled syringe 13/07/2012
H0473-5 30 Sep 2014 1 x 0.5ml pre-filled syringe Released 25/07/2012*
H0473-6 30 Sep 2014 10 x 0.5ml pre-filled syringe 03/09/2012
H0539-3 31 Oct 2014 10 x 0.5ml pre-filled syringe 05/09/2012

*This batch has not been distributed in the UK by Sanofi Pasteur MSD. It is included in the listings, however, as it is possible that it may have been imported into the UK by a European wholesaler.