| TGA Action ID |
RC-2025-RN-00404-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Baby & Child Teething Gel
Batch Numbers: 27266, 27268, 27272, 26846, 26848, 26850, 26852, 27185, 27187, 27189, 27264
Expiry Dates: Nov 2026, Dec 2026, Jan 2027, Feb 2027 |
| ARTG Number |
347981 |
| Action Type |
Recall |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
During routine finished product testing by the manufacturer, a small piece of plastic identified as being broken off plastic, known as a ‘flash’ from the rim of the tube was found to be present in the gel when squeezed from the tube. The plastic flash is thin and about 6 mm in length.
This product defect presents a serious risk to patients. The 6 mm plastic fragment may not be identified by parents/caregivers administering the gel to a crying baby.
The parents/caregivers are not always likely to detect the small piece of plastic, and when applying/rubbing the gel onto the gum of a distressed child, they may not be able to retrieve the plastic even if they feel it, before it is ingested/inhaled.
Ingestion/inhalation of the plastic fragment could cause choking and/or local trauma and bleeding, which could require a hospital presentation and urgent medical attention. |
| Instructions for Customers/Users |
- Customers are to quarantine affected batches: 27266, 27268, 27272, 26846, 26848, 26850, 26852, 27185, 27187, 27189, 27264 on hand to prevent further use and return them to Brauer.
-Retailers are advised to display the Public Notice enclosed with this letter at the front of their store to inform consumers.
- Consumers are to return the products to the stores (or points of purchase), and the store staff shall do full refund to the customers.
This action has been closed out on 07/10/2025. |
| Action Commencement Date |
5/05/2025 |
| Responsible Entity |
|
| Contact Information |
1300308108 - custserv@brauer.com.au - Brauer Natural Medicine |