| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2022-RN-01352-1 |
| Product Name/Description |
Sanjin Watermelon Frost Insufflation
Batch number: A019121
Expiry date: 3/12/2022
ARTG 176677
(Sanjin Watermelon Frost Insufflation) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/11/2022 |
| Responsible Entity |
|
| Reason/Issue |
Shen Neng Herbal Medicines Group has become aware of an issue with the IFU for Sanjin Watermelon Frost Insufflation, a powder spray for oral application. The instructional leaflet enclosed with every bottle contains a series of diagrams showing users how to use the product safely. One diagram is shown out of order and with no context, it appears as is the correct use of the product is to remove the dosing component from the bottle and pour powder out unrestricted. As this is a powder for oral application, there is a possibility that the user may subsequently experience an overdose of Boron.
Sanjin Watermelon Frost Insufflation contains Boron 15.1mg per gram of ingrediant Borax, subject to elemental boron restriction of 6mg/day. Proper use of the product up to the maximum recommended daily dose would deliver 0.755mg of elemental boron, well within the daily limit.. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Retailers will be contacted and required to display the Product Defect Alert poster in their storefronts to alert customers. This poster will address the potential overdose issue, featuring a correct leaflet.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
enquiries@shennenggroup.com
ph: 02-94169831 |