SHEN NENG FANG FENG TONG SHENG WAN (Shen Neng Herbal Medicines Group Pty Ltd)
Product Name
SHEN NENG FANG FENG TONG SHENG WAN
ARTG
69602
Date of review outcome
Date of publication
Sep-22
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
The affected batch (EYD05616L1) of the medicine expired in April 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 label for the medicine was missing the mandatory warning statement 'Use in children under 12 years is not recommended’.
While this is unacceptable, the label provided a dosage for adults only, not children, and included the statements 'If digestive symptoms persist, please seek medical advice’ and 'Prolonged use of laxatives is undesirable and may lead to dependence’, which alert consumers to possible effects of the medicine. Additionally, supply of the medicine without the warning statement ceased in July 2020 and the affected batch has now expired.
As such, the medicine is unlikely to pose an immediate risk to consumer health and safety.
While this is unacceptable, the label provided a dosage for adults only, not children, and included the statements 'If digestive symptoms persist, please seek medical advice’ and 'Prolonged use of laxatives is undesirable and may lead to dependence’, which alert consumers to possible effects of the medicine. Additionally, supply of the medicine without the warning statement ceased in July 2020 and the affected batch has now expired.
As such, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The label claimed that the medicine may assist in the treatment of constipation. However, this claim was not covered by the sponsor’s certification that they held evidence to substantiate it.
Actions taken during the review
The sponsor updated the labels for the medicine.
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 provide information requested as part of the compliance review.
The TGA then issued an educational letter to the sponsor. The sponsor was not required to respond. They cancelled the medicine and withdrew it from further supply.
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 provide information requested as part of the compliance review.
The TGA then issued an educational letter to the sponsor. The sponsor was not required to respond. They cancelled the medicine and withdrew it from further supply.
Additional information
This review was conducted as part of a targeted project