Chlorofluor Gel

Update - additional information about recall process

5 July 2016

Consumers and health professionals are advised that Professional Dentist Supplies has provided additional details about the recall process and the information below has been updated.

If you have Chlorofluor Gel (all bottle sizes) from batch number BK 119, stop using it. Return it to the place of purchase for a refund or call Professional Dentist Supplies' customer service line on (03) 9761 6615 to arrange for the return of affected product and a refund.

Recall - potential risk of infection due to bacterial contamination

30 June 2016

Consumers and health professionals are advised that Professional Dentist Supplies, in consultation with the TGA, is recalling batch number BK 119 of Chlorofluor Gel (all bottle sizes) due to bacterial contamination.

Chloroflour Gel bottles

Chlorofluor Gel is an oral hygiene product containing 2 mg/ml chlorhexidine. It can be purchased over-the-counter and is used in private settings, as well as in hospitals.

The contamination was identified following a cluster of cases of colonisation or infection in intensive care patients at a single hospital. Investigations are ongoing but have included testing of unopened bottles of Chlorofluor Gel from the same batch that was used in the treatment of the affected patients. This testing detected high levels of Burkholderia cepacia (B. cepacia).

B. cepacia poses little medical risk to healthy people. However, people with weakened immune systems, such as intensive care patients, may be more susceptible to B. cepacia infections and at increased risk of associated health problems.

The effects of B. cepacia infection vary widely, ranging from no symptoms at all, to serious respiratory infections, especially in patients with chronic lung diseases, such as cystic fibrosis.

Information for consumers

If you have Chlorofluor Gel, check the batch number located on the label.

If it is from batch number BK 119, stop using it. Return it to the place of purchase for a refund or call Professional Dentist Supplies' customer service line on (03) 9761 6615 to arrange for the return of affected product and a refund.

If you have any questions or concerns about this issue, talk to your health professional.

Information for health professionals and hospitals

Please be aware of this issue.

If you have Chlorofluor Gel from batch number BK 119, stop using it.

Professional Dentist Supplies is undertaking a recall of batch number BK 119. Return it to the supplier for a refund or call Professional Dentist Supplies' customer service line on (03) 9761 6615 to arrange for the return of affected product and a refund.

If you are treating a patient who has used Chlorofluor Gel and is showing clinical signs of infection, ensure you include potential exposure to B. cepacia via Chlorofluor Gel in the clinical notes of the pathology referral form.

It is not necessary to test patients for B. cepacia if they are not showing signs of infection.

If you identify any cases of infection with B. cepacia, consult the public health unit/health department in your state or territory. If you suspect a link between a case of infection and use of Chlorofluor Gel, please report it to the TGA as an adverse event.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA’s monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.