| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2019-RN-01721-1 |
| Product Name/Description |
Brauer Teething Gel 20g tube
Batch Number: 809057
Expiry Date: Sep20
This product is exempt from ARTG registration |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/11/2019 |
| Responsible Entity |
|
| Reason/Issue |
Brauer advises that following receipt of a customer complaint that the product was ‘more runny’ than usual, investigations were conducted and testing was performed on retention samples and the customer complaint sample.
Investigations determined that a higher than usual microbial count may impact this particular batch.
Microbiological Identification has been performed returning a positive result for presence of Burkholderia spp.
The health risk associated with this issue is minor to serious infection in infants.
To date there have been no reports of patient harm. |
| Recall Action |
Recall |
| Recall Action Instructions |
CONSUMERS:
Consumers are requested to immediately stop using stock from this particular batch and return any affected goods to the place of purchase for a suitable refund or exchange or contact Brauer customer service for further assistance.
DISTRIBUTORS/PHARMACIES/HEALTH FOOD STORES:
Distributors and Retailers are requested to immediately quarantine affected goods from this batch on site and contact Brauer to organise the return of affected goods for a suitable exchange or account credit.
Further information is available on the TGA website: https://www.tga.gov.au/alert/brauer-teething-gel-20-g
This action has been closed out on 15/10/2020 |
| Contact Information |
1300 308 108 - Brauer Customer Service |