Throat Comforting Granules (previously Strepper-Throat Comforting Granules) (Shen Neng Herbal Medicines Group Pty Ltd)
Product Name
Throat Comforting Granules (previously Strepper-Throat Comforting Granules)
Date of review outcome
Date of publication
Sep-22
Outcome
Medicine continues to be permitted for supply. Batches released from 30 June 2022 must carry a corrected label with the updated name of 'Throat Comforting Granules’.
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
The affected batch (17060521) of the medicine expired in June 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 name included the term 'Strepper-Throat', which implies a serious form of throat infection (strep throat) that requires medical diagnosis and treatment, particularly in high-risk individuals.
Claims implying health benefits related to a serious form of an infectious disease are not permitted for medicines that are available for self-selection without prior evaluation by the TGA. Use of the medicine, without involvement of a suitably qualified health professional, may lead to inappropriate use of this medicine by consumers and delay access to timely medical advice, which may result in adverse outcomes for some individuals.
However, the medicine is unlikely to pose an immediate risk to consumers, as the medicine's label warns consumers to talk to a healthcare practitioner if symptoms persist. In addition, batches of the medicine with the name 'Strepper-Throat Comforting Granules’ have not been supplied since March 2020, and the last affected batch expired in June 2022.
Claims implying health benefits related to a serious form of an infectious disease are not permitted for medicines that are available for self-selection without prior evaluation by the TGA. Use of the medicine, without involvement of a suitably qualified health professional, may lead to inappropriate use of this medicine by consumers and delay access to timely medical advice, which may result in adverse outcomes for some individuals.
However, the medicine is unlikely to pose an immediate risk to consumers, as the medicine's label warns consumers to talk to a healthcare practitioner if symptoms persist. In addition, batches of the medicine with the name 'Strepper-Throat Comforting Granules’ have not been supplied since March 2020, and the last affected batch expired in June 2022.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor updated the label and ARTG record by changing the name of the medicine to 'Throat Comforting Granules’.
Additional information
This review was conducted as part of a targeted project