Sanjin Watermelon Frost Insufflation
URGENT PRODUCT DEFECT ALERT - Unclear instructions may lead to boron overdose
Consumers are advised that Shen Neng Herbal Medicines Group Pty Ltd has initiated a product defect alert for Sanjin Watermelon Frost Insufflation.
Only lot AO19121 of Sanjin Watermelon Frost Insufflation is affected.
This lot will expire on 03 Dec 2022.
What are the problems?
Sanjin Watermelon Frost Insufflation, lot AO19121 includes an instructional insert with diagrams.
One diagram is shown out of order and instructs users to remove the dosing nozzle of the medication and pour out the medicinal powder.
This may be misinterpreted and users may pour the medicine onto the affected area.
If you ingest a higher dose than is safe to do so, you may take an overdose of boron.
What are the risks?
Boron overdose may have adverse consequences to fertility. This medicine does not advise additional caution for children and pregnant women.
No complaints or adverse events about this issue have been received.
What do I need to do?
If you use Sanjin Watermelon Frost Insufflation, check the lot number on the packaging.
If the lot number is AO19121, follow the updated instructions for use which are given below.
If consumers follow the updated instructions, there is no risk of a boron overdose.
Future lots of Sanjin Watermelon Frost Insufflation will include these updated instructions.
Customers can contact Shen Neng Herbal Medicines Group Pty Ltd at 02 9416 9831 or via email at enquiries@shennenggroup.com if they have additional questions.
How will this issue be fixed?
Shen Neng Herbal Medicines Group Pty Ltd has updated their instructional insert to include new instructions.
Traditional Chinese medicine retailers have been contacted and asked to display a notice of this correction in stores. This will help keep consumers informed about the safe and correct use of the product.
Consumers who are concerned in any way about the use of this product should consult their doctor.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
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 medical device.