HSA Alerts Public of the Voluntary Recall of “Care Wipes”, “Trihexid Chlorhexidine 0.2% Mouth Rinse” and “Pearlie White Fluorinze Fluoride Mouth Rinse”

The Health Sciences Authority (HSA) is alerting the public on the voluntary consumer level recall by the companies distributing the following products:

• “Care Wipes” by Tai Sun Paper Products Pte Ltd (Singapore) 
• “Trihexid Chlorhexidine 0.2% Mouth Rinse” by Trident Pharm Pte Ltd 
• “Pearlie White Fluorinze Fluoride Mouth Rinse” by Corlison Pte Ltd

2      Certain batches of these products were found to be contaminated with the bacteria, Burkholderia cepacia (B. cepacia).

3       “Care Wipes” is a disposable skin cleansing wipe. “Trihexid Chlorhexidine 0.2% Mouth Rinse” is labelled for use in the prevention of bad breath, tooth and gum diseases, reduction of plaque build-up, mouth ulcers and oral care following surgery. “Pearlie White Fluorinze Fluoride Mouth Rinse” is labelled to help kill bacteria that cause bad breath, plaque and gum problems, relieve tooth sensitivity, prevent tooth decay, strengthen tooth enamel and freshen breath.

4      Says Ms Chan Cheng Leng, Division Director of Vigilance “Following the detection of contamination of Oral Guard Mouthwash last month, HSA stepped up our routine surveillance and testing of health products as a precautionary measure to ensure that these products meet the required standards of quality. A risk-based approach towards product sampling was taken, which took into consideration the products most likely to be contaminated by B. cepacia. The products tested include those used in hospitals and the more commonly used mass-market brands of consumer health products. HSA will also continue to keep members of the public informed of any significant safety findings arising from its surveillance and product testing.” 

5      B. cepacia is a bacterium that can be found in water, soil and other moist environmental sources. B. cepacia poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases may be more susceptible to infections with B. cepacia. There have been reported cases of B. cepacia detected in products such as mouth rinses and cleansing wipes in other parts of the world. 

6      Due to the potential risk of infections associated with B. cepacia in susceptible individuals, a voluntary consumer level recall of all batches of “Care Wipes”, “Trihexid Chlorhexidine 0.2% Mouth Rinse” and “Pearlie White Fluorinze Fluoride Mouth Rinse” has been initiated as a precautionary measure.

HSA's actions 

7      HSA is currently overseeing the voluntary recall of the affected products and working with the companies to identify the root cause of B. cepacia contamination in the products. Meanwhile, HSA will continue to monitor the situation closely and continue with its tests. Members of the public will be informed of any significant safety findings arising from its surveillance and product testing. 

Consumer advisory 

8      Consumers should stop the use of “Care Wipes”, “Trihexid Chlorhexidine 0.2% Mouth Rinse” and “Pearlie White Fluorinze Fluoride Mouth Rinse”. Those who have already used the products should not be unduly concerned as B. cepacia poses little medical risk to healthy people. Those who have health concerns should contact their doctors. 

9      Consumers who have queries relating to the recall of the affected products may wish to contact the respective companies as follows:

"Care Wipes"

“Trihexid Chlorhexidine 0.2% Mouth Rinse”

“Pearlie White Fluorinze Fluoride Mouth Rinse”

HEALTH SCIENCES AUTHORITY
SINGAPORE
30 DECEMBER 2010

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