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Consumer level recall of dental hygiene products.



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TGA - Therapeutic Goods Administration Regulating Australia's medicines, medical devices, blood, tissues and chemicals

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Consumer level recall of dental hygiene products

Media release

● Printable version of Consumer level recall of dental hygiene products

media release

● Recall notice - Colgate Periogard Chlorohex

24 September 2004

Colgate-Palmolive Australia have announced a national recall, to consumer level of all batches of the following products:

Colgate Periogard Clorohex Antiseptic Mouth Rinse AUST R 26774 Colgate Periogard Clorohex Antiseptic Mouth Gel AUST R 26783 Colgate Periogard Clorohex Forte Antiseptic Mouth Gel AUST R 26685

The company has been consulting with the Therapeutic Goods Administration and have taken this action following a report of contamination of some bottles of the mouth rinse with the bacterium Burkholderia cepacia and instances of infection in a single hospital. The TGA regards the action taken by the company as appropriate.

THIS BACTERIUM IS NOT A LIKELY SOURCE OF INFECTION TO HEALTHY PEOPLE. THE TGA IS CONCERNED, HOWEVER, THAT THERE MAY BE AN INCREASE RISK OF INFECTION IN PERSONS WITH CYSTIC FIBROSIS, IMMUNOSUPPRESSED PATIENTS AND PATIENTS IN INTENSIVE CARE ENVIRONMENTS.

The products are distributed principally through dental surgeries and hospitals but are also available in limited numbers through pharmacies. Consumers who have any of the above products are advised to cease using them. Any one

who is concerned in any way about their use of these products should consult their healthcare professional.

The TGA has put into action an investigation into the circumstances surrounding the manufacturing of these products.

Media contact: John Noble, Media Adviser, TGA 0413 890 241

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Web page produced by Therapeutic Goods Administration, 24 September 2004 Publication content last modified on 24 September 2004 by Therapeutic Goods Administration Web page last modified on 24 September 2004 by Therapeutic Goods Administration URL: http://www.tga.gov.au/media/2004/040924_colgate.htm

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