Press Releases
HSA Alerts Public on the Recall of "Oral Guard Antiseptic-Antiplaque Mouthwash"
Audiences
Consumer
Healthcare professional
Industry member
Product type
Others
18 November 2010
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The Health Sciences Authority (HSA) would like to update healthcare professionals on the voluntary consumer level recall of all batches of “Oral Guard Antiseptic-Antiplaque Mouthwash” which was found to be contaminated with Burkholderia cepacia (B. cepacia), a gram-negative bacillus.
2 The recall was initiated as a precautionary measure as the contaminated product may pose a health risk to susceptible individuals. This communication serves to alert healthcare professionals that their patients who were using “Oral Guard Antiseptic-Antiplaque mouthwash” might have been exposed to B. cepacia.
Background information
3 Samples of “Oral Guard Antiseptic-Antiplaque Mouthwash” were sent for microbial tests as part of HSA's product quality sampling checks. The microbial test reports revealed the presence of B. cepacia in the following batches of the product: 060813, 070813 and 080813. Results of the other batches are still pending. Due to the potential risk of infections associated with B. cepacia in susceptible individuals, a voluntary recall to the consumer level of all batches of “Oral Guard Antiseptic-Antiplaque Mouthwash” is being implemented as a precautionary measure.
4 “Oral Guard Antiseptic-Antiplaque Mouthwash” contains chlorhexidine gluconate as the active ingredient and is labelled for use in a number of dental conditions such as gingivitis, dental plaque, mouth ulcers and maintenance of oral hygiene. It is manufactured by Group Pharmaceuticals Ltd, India and distributed by IDS Pharmaceutical Division mostly to healthcare institutions such as hospitals, specialist institutions, dental clinics and polyclinics and to limited retail outlets.
About Burkholderia cepacia (B. cepacia)
5 B. cepacia is a gram-negative bacterium that can be found in water, soil and other moist environmental sources. It poses little medical risk to healthy people. However, individuals who are immunocompromised or have certain medical conditions like chronic lung diseases may be more susceptible to severe infections with this bacterium. The effects of B.cepacia on people can vary widely, ranging from no symptoms at all, to serious respiratory infections (especially in individuals with cystic fibrosis). There have been reported cases of B. cepacia-contaminated chlorhexidine mouthwash in other parts of the world such as the United States.
HSA’s actions and advisory
6 HSA is overseeing the voluntary recall of the mouthwash from healthcare institutions and retail outlets, which is expected to be completed by the end of the week. In addition, Medimex Singapore, the importer of the product, will be placing a public advertisement regarding the recall of the mouthwash in the local newspapers to inform consumers to stop using the mouthwash and return the product to the respective place of purchase.
7 Healthcare professionals are advised to stop prescribing “Oral Guard Antiseptic-Antiplaque Mouthwash” to patients and encouraged to be vigilant to possible adverse effects which may arise from the use of the contaminated mouthwash, especially in individuals who are immunocompromised or have chronic lung diseases.
8 Consumers who have queries related to the return of the product may wish to contact Medimex Singapore at tel: 6779-5579 between 9am-5pm (Monday to Friday) or email: enquiry@medimex.com.sg.
HEALTH SCIENCES AUTHORITY
SINGAPORE
18 NOVEMBER 2010