Consumers and health professionals are advised that Brauer Natural Medicine, in consultation with the TGA is recalling one batch of Brauer Teething Gel 20 g due to bacterial contamination.
Brauer Teething Gel is used to reduce the discomfort caused by teething in babies.
The affected batch is 809057 with an expiry date of September 2020. This batch has been distributed to pharmacies, health food stores and sold via the internet since 24 October 2018.
Testing has found that some samples from this batch have been contaminated with Burkholderia, a bacteria commonly found in soil, water and the general environment. They are capable of causing infections in healthy hosts, but in particular affect those with compromised immune systems. These bacteria can be also spread through person-to-person contact.
The initial symptoms of Burkholderia infection may be a low-grade fever, potentially progressing to much more serious conditions, including pneumonia and other lung disorders.
Information for consumers
Consumers who use Brauer Teething Gel are advised to check the batch number on the packaging. If it is from batch 809057 you should immediately stop using the product.
Infants, in whom this product is most likely to be used, have an immature immune system and are therefore more susceptible to infection than healthy adults. In infants who have been treated with the affected gel be alert to the potential signs of Burkholderia infection such as low-grade fever. Seek immediate medical advice if you suspect infection.
You should return affected goods to the place of purchase or contact Brauer customer service to arrange product return and a refund. For further information, call Brauer Customer Service on 1300 308 108.
Information for health professionals
If you are treating somebody who uses Brauer Teething Gel advise them of this issue and the symptoms that might indicate Burkholderia infection.
If you are a pharmacist who sells this product inspect your stock immediately and quarantine any units of the affected batch 809057 to prevent further use. If you have supplied or transferred any potentially affected product to another facility or organisation, let that facility know of the recall immediately.
For further information on the recall process call Brauer Customer Service on 1300 308 108.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.