| TGA Action ID |
RC-2026-RN-00638-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Tooth Mousse Plus - Strawberry Flavour
Lot Number: 260311E
REF: 464357
Expiry Date: 08/09/2028 |
| ARTG Number |
271415 |
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class III |
| Reason for the Action |
GC Australasia Dental has reported a labelling error regarding the carton (tube box) of Tooth Mousse Plus - Strawberry Flavour. The product is correctly packaged in the Tooth Mousse Plus - Strawberry tube, outer 10 pack box, and contains the Instructions for Use for Tooth Mousse Plus. However, the carton (tube box) is incorrect as it is labelled as the Tooth Mousse box. Tooth Mousse Plus contains 900ppm of fluoride while Tooth Mousse is fluoride free.
There is no risk of using Tooth Mousse Plus in children as it contains fluoride within the tolerable fluoride limit. |
| Instructions for Customers/Users |
Wholesalers and Retailers are to:
- Inspect stock on hand immediately and quarantine affected stock with Lot Number 260311E to prevent further use.
- Complete the attached Customer Response form and return it to justine@piksters.com.
- Unaffected Tooth Mousse Plus - Strawberry, is a suitable replacement which is currently available for order. Please contact justine@piksters.com to arrange for replacement. |
| Action Commencement Date |
21/08/2026 |
| Responsible Entity |
|
| Contact Information |
1800 817 155 - GC Australasia Dental |