COMMUNICABLE DISEASE 
CONTROL BRANCH
- Attention all doctors - 
Date: 1/07/2016     Contact telephone number: 1300 232 272  (24 hours/7 days)

 

Chlorofluor gel contamination

SA Health has become aware that a batch (BK 119, expiry 11/2017) of Chlorofluor Gel® (Professional Dental Supplies) is contaminated with Burkholderia cepacia.

B. cepacia infections were noted in two patients in the same ward at the Royal Adelaide Hospital and a subsequent investigation seeking the source of infections has identified contamination of Chlorofluor Gel® with B. cepacia.

The Therapeutic Goods Administration (TGA) is aware of the issue. A consumer level recall of the product is underway. For further information see https://www.tga.gov.au/alert/chlorofluor-gel.

B. cepacia is a Gram-negative bacterium which is commonly found in soil and water. B. cepacia rarely causes infection in healthy people. It may cause sepsis and respiratory infections in immunosuppressed persons, and persons with chronic lung disease such as cystic fibrosis.

Chlorofluor Gel® aids in the treatment of gingivitis and dental plaque, helps prevent tooth decay and helps reduce the discomfort and duration of mouth ulcers. It can be purchased over the counter. Chlorofluor Gel® may be used in many areas such as in intensive care, stroke units, aged care and after dental procedures. The contaminated batch has been in the marketplace since late last year. All available sizes (30 mL, 100 mL and 250 mL) of batch BK 199 are potentially contaminated. Testing of other batches has to date not revealed any contamination.

Doctors are advised to:
· Cease use of and quarantine any Chlorofluor Gel® of batch BK 119, expiry 11/2017.
· Diagnose and manage persons suspected of B. cepacia infection in accordance with usual clinical processes.
· Send clinical specimens for culture as appropriate for any patients with sepsis, and if they have used Chlorofluor Gel® please note this on the request form.
· Do not test asymptomatic patients who have used Chlorofluor Gel®.
· Report any cases of B. cepacia infection with a suspected link to Chlorofluor Gel® to the Communicable Disease Control Branch on 1300 232 272 (24 hours/7 days) and/ or to TGA.

Dr Ann Koehler - Director, Communicable Disease Control Branch
For all enquiries please contact the CDCB on 1300 232 272 (24 hours / 7 days)
Public – I4-A1

Download the official health alert here (PDF)
 

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