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Chlorofluor Gel Batch Recall

01/07/2016  |  Tags: Chlorofluor Gel Batch Recall,

Professional Dentist Supplies, in consultation with the TGA, is recalling batch number BK119 of Chlorofluor Gel (all bottle sizes) due to a bacterial contamination. Testing has revealed high levels of Burkholderia cepacia (B. cepacia) after intensive care patients became infected at a single hospital.

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

Further information, including details of the recall procedure, will be sent to hospitals, pharmacies and other distributors, including dental suppliers. In the meantime, check all bottles of Chlorofluor Gel and quarantine any from batch BK 119.

If you are treating a patient who has used Chlorofluor Gel and is showing clinical signs of infection, ensure you test for B. cepacia. 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. It is not necessary to test patients for B. cepacia if they are not showing signs of infection.