Sanjin Watermelon Frost Insufflation (Shen Neng Herbal Medicines Group Pty Ltd)
Product Name
Sanjin Watermelon Frost Insufflation
ARTG
176677
Date of review outcome
Date of publication
Mar-23
Outcome
Medicine continues to be permitted for supply. Batches released after 2 December 2022 must have corrected carton inserts and labels.
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, follow the recommended actions below.
What action should consumers take?
The affected batch of the medicine (A019121) expired in December 2022 and consumers should not be taking expired medicines
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
The medicine contains the ingredient borax, which contains boron, a potentially harmful substance if consumed in excess. There are quantity restrictions in place for boron to ensure the safe use of listed medicines. The carton insert included with the medicine contained instructions that could lead to a consumer taking too much boron at one time. A product defect alert (https://www.tga.gov.au/safety/safety/product-alerts/sanjin-watermelon-frost-insufflation) was issued for the medicine, alerting consumers to issues with the medicine instructions. The sponsor has amended the carton insert for future batches of the medicine.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA issued an infringement notice (https://www.tga.gov.au/media-release/shen-neng-herbal-medicines-group-pty-ltd-fined-53280-alleged-breaches-therapeutic-goods-legislation) to the sponsor for failing to inform the Secretary of a new manufacturer of the medicine within the required timeframe.
In addition, the TGA required the sponsor to correct the issues with the medicine. The sponsor updated the carton insert and the ARTG record and committed to updating the labels for the medicine. A product defect alert was issued for the medicine.
In addition, the TGA required the sponsor to correct the issues with the medicine. The sponsor updated the carton insert and the ARTG record and committed to updating the labels for the medicine. A product defect alert was issued for the medicine.
Additional information
This review was conducted as part of a targeted project