Medical safety alert

Typhim Vi - Typhoid Polysaccharide Vaccine - antigen levels below required specification

(Sanofi Pasteur MSD) Some batches may have antigen levels below required specification – class 2 action within 38 hours. (EL (12)A/33)

08 October 2012

Class 2 medicines recall

Action within 48 hours

Pharmacy and equivalent-level recall

MDR 42-09/12

Product details

Sanofi Pasteur MSD Limited

Typhim Vi

(Typhoid Polysaccharide Vaccine)

PL 06745/0039

Alert details

Sanofi Pasteur MSD is recalling 16 batches of the above product because the results of recent investigations have indicated that some syringes within them may potentially have antigen levels which are below the required specification. This means that some individuals who have been vaccinated with Typhim Vi since 7 January 2011 may be insufficiently protected against typhoid. Not all doses in these batches are affected but it is not possible to predict who may have received the affected doses. We understand 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. There is a licensed oral typhoid vaccine available on the UK market but stocks of this are also limited. 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.

Batch details are presented on page 2 of this notification. 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 0800 0858958

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

Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics and to general practitioners and community pharmacists for information.

Typhim Vi batches being recalled

Batch number   Expiry date   Pack size   Date of first distribution
G0069-1   31 January 2013     1 x 0.5ml pre-filled syringe   07/03/2011
G0069-2   31 January 2013   10 x 0.5ml pre-filled syringes   07/01/2011
G0069-3   31 January 2013   10 x 0.5ml pre-filled syringes   08/02/2011
G0327-3   30 June 2013     1 x 0.5ml pre-filled syringe   11/04/2011
G0327-4   30 June 2013   10 x 0.5ml pre-filled syringes   28/04/2011
G0529-2   30 September 2013     1 x 0.5ml pre-filled syringe   19/06/2012
G0530-1   30 September 2013   10 x 0.5ml pre-filled syringes   28/03/2012
G0563-1   30 September 2013   10 x 0.5ml pre-filled syringes   21/07/2011
G0574-1   31 October 2013   10 x 0.5ml pre-filled syringes   03/08/2011
G0574-6   31 October 2013   10 x 0.5ml pre-filled syringes   18/10/2011
H0048-1   31 January 2014     1 x 0.5ml pre-filled syringe   04/10/2011
H0048-6   31 January 2014     1 x 0.5ml pre-filled syringe   01/12/2011
H0473-1   30 September 2014   10 x 0.5ml pre-filled syringes   13/07/2012
H0473-5   30 September 2014     1 x 0.5ml pre-filled syringe   Released  25/07/2012 *
H0473-6   30 September 2014   10 x 0.5ml pre-filled syringes   03/09/2012
H0539-3   31 October 2014   10 x 0.5ml pre-filled syringes   05/09/2012
  • This batch has not been distributed in the UK by Sanofi Pasteur MSD. It is included in the listing, however, as it is possible that it may have been imported into the UK by a European wholesaler

MHRA distribution

Further recipients by cascade:

Regional Contacts for NHS Trusts and provider units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief Pharmacists:  Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special Hospitals
Healthcare Commission for distribution to independent health care establishments
Primary care trusts (England)

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