Product Recall

 

Following consultation with the TGA, GlaxoSmithKline Australia Pty Ltd is conducting a sponsor initiated recall of:

Product:

INFANRIX hexa Vaccine

Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B

Poliovirus and Haemophilus influenzae type b vaccine

Aust R:

132881

Batch Numbers:

A21CB144A

A21CB188D

A21CB188E

A21CB190A

A21CB197A

A21CB221B

Expiry Date:

31st January 2014

 

This recall has been initiated because a surface in a manufacturing area was found to be contaminated with the bacterium Bacillus cereus, an organism commonly found in food and soil. No contamination of the ingredients or in the vaccine itself was found and all the batches passed quality and sterility testing before release in Australia.

There is no concern regarding the safety for patients. Those who have received vaccination from the affected batches do not require revaccination.

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 replaced or 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.

No other batches of INFANRIX hexa Vaccine or any other GSK vaccines are affected by this recall. Other batches are available and no supply problems are anticipated.

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 GlaxoSmithKline on 1800 064 162

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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