Product Recall

 

Following consultation with the TGA, Sanofi-Aventis Pty Ltd (trading as Sanofi Pasteur) is conducting a sponsor initiated recall of:

TYPHIM VI (Salmonella typhi Vi polysaccharide) Vaccine 25µg/0.5mL
Aust R : 45073

Carton Batch Number

Syringe Batch Number

Expiry date

E1246 – 3

E1246

10/2012

G0461 – 2

G0461

08/2013

H0078 – 3

H0078

01/2014

H0078 – 4

H0078

01/2014

H0101 – 1

H0101

02/2014

H0198 – 5

H0198

04/2014

H0507 – 1

H0507

09/2014

 

This recall has been initiated because these syringes have been found to have variable antigen content, which may result in reduced efficacy, because of a problem with the filling process.

There is no concern regarding the safety for patients. Those who have received vaccination from the affected batches are not advised to repeat the dose earlier than recommended, although the level of immunity is not quantified.

Please inspect your stocks and quarantine all units from the above batch numbers for return to your supplier who will arrange for stock to be refunded. Any items from these batches supplied by HPS Pharmacies should be returned to the Pharmacy for processing. If any stock has been transferred to other units, please forward this notice on to them. Check also any supplies allocated to patients.

No other batches of TYPHIM VI Vaccine are affected but these may not be sufficient for all requirements until new stock is available in early 2013. Should TYPHIM VI Vaccine become unavailable, three alternative vaccines that may be used are:-

  • TYPHERIX (Salmonella typhi Vi polysaccharide, GSK)
  • VIVOTIF (Salmonella typhi Ty21a, CSL)
  • VIVAXIM (Salmonella typhi Vi polysaccharide and inactivated hepatitis A virus antigen, Sanofi)

Please retain this notice in a prominent position for one month in case stock is in transit.

Should you require further information regarding this matter, please do not hesitate to contact your pharmacist at HPS Pharmacies or Sanofi Pasteur Customer Service on 1800 829 468.

Information regarding expected dates for supply may vary subject to delays which are out of our control. HPS Pharmacies does not accept responsibility for such changes but will endeavour to keep our clients updated as information is made available from drug manufacturers or wholesalers.

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