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Typhim Vi typhoid polysaccharide vaccine

Class 2 Medicines Recall – Action Within 48 hours

Ref: EL(12) A/33

Typhim Vi (typhoid polysaccharide vaccine)
(Sanofi Pasteur MSD)

PL 06745/0039

Sanofi Pasteur MSD is recalling 16 batches of Typhim Vi (PL 06745/0039) because some products may have antigen levels below the required specification. Not all batches are affected but it is not possible to predict who has received an affected product; individuals who have received the Typhim Vi vaccine since 7 January 2011 may be insufficiently protected against typhoid.

There are no additional safety concerns associated with the affected batches.

Due to the recall, Typhim Vi is expected to be out of stock by the end of October 2012 and it is unknown when normal supply of the vaccine will resume. Due to the out of stock situation, it will not be possible to revaccinate individuals who may not have received a vaccine that gave them complete protection.

A licensed oral vaccine is available in the UK, but stocks of this vaccine are limited. Travellers should be advised on the importance of exercising scrupulous food and water hygiene precautions when visiting areas where typhoid is prevalent.

Remaining stock of the affected batches should be quarantined and returned to the original supplier for credit. For stock-related enquires, Sanofi Pasteur MSD customer services is available on 0800 0855511 (fax 0800 0858958). Medical information is available on 0800 7311654 (fax 01628 635072).

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 27.07.2012*
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 05.09.20.12

* This batch has not been distributed in the UK by Sanofi Pasteur MSD. It is included in the listing because it is possible it may have been imported into the UK by a European wholesaler. 

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