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SHEN NENG ER CHEN WAN (Shen Neng Herbal Medicines Group Pty Ltd)
Product Name
SHEN NENG ER CHEN WAN
ARTG
56467
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?
Be aware that the labels for this medicine are missing the warning statement 'Products containing activated charcoal should be used with caution in children since it may interfere with absorption of nutrients. It may interact with other medicines and is not recommended for long-term use.'
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 for activated charcoal, as set out under 'what actions should consumers take’. This warning statement is necessary to ensure the safe use of the medicine and to alert consumers to safety risks prior to taking the medicine.
While this omission is unacceptable, the label does include the statement 'Adult only’, and the quantity of activated charcoal present in the medicine is unlikely to pose an immediate risk to consumer health and safety. Additionally, supply of the medicine without the warning statement ceased in July 2020.
While this omission is unacceptable, the label does include the statement 'Adult only’, and the quantity of activated charcoal present in the medicine is unlikely to pose an immediate risk to consumer health and safety. Additionally, supply of the medicine without the warning statement ceased in July 2020.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
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