Contaminated mouth wash recalled
A common mouth wash and denture cleaner has been recalled after being blamed for a rash of infections among intensive care patients at a hospital.
Batches of Chlorofluor Gel, which is taken to help treat mouth infections and is often used as a post-operative treatment following teeth extraction and other oral surgery, have been found to be heavily contaminated with a bacteria that can cause serious infections in patients with chronic lung diseases such as cystic fibrosis.
The Therapeutic Goods Administration has called on all those with Chlorofluor Gel from with a batch number BK 119 to immediately stop using the preparation, and distributor Professional Dentist Supplies has undertaken a nationwide recall of the product.
The TGA said the contamination was discovered after a group of intensive care patients at an unnamed hospital were found to be colonised or infected with the bacterium Burkholderia cepacia.
Investigations found that Chlorofluor Gel used to treat the patients, as well as from unopened containers in the same batch, were contaminated with high levels of B. cepacia. The contamination was found in all bottle sizes of the formula from the same batch.
The medicines watchdog said that although the bacterium posed little threat to healthy people, those with weakened immune systems, such as intensive care patients, might be more susceptible to infection 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 regulator said.
Chlorofluor Gel can be purchased over-the-counter, and those with products from the contaminated batch have been advised to return it to the place of purchase to get a refund, or to call Professional Dentist Supplies on 03 9761 6615 to arrange for the affected product to be collected and receive a refund.
Doctors treating patients who have used Chlorofluor Gel and who are showing signs of infection are being advised to include potential exposure to B. cepacia in clinical notes accompanying a pathology referral. The TGA said a test was unnecessary if patients were showing no signs of infection.