PRA number
2016/15493
Published date
Product description
Chlorofluor Gel is an oral hygiene product containing 2 mg/mL chlorhexidine.
Reasons the product is recalled
Testing detected high levels of Burkholderia cepacia (B. cepacia).
The hazards to consumers
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.
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.
What consumers should do
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.
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.
Supplier
Professional Dentist Supplies
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.