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SHEN LING BAI ZHU WAN (Shen Neng Herbal Medicines Group Pty Ltd)

Product Name
SHEN LING BAI ZHU WAN
Date of review outcome
Date of publication
Sep-22
Outcome
Medicine continues to be permitted for supply. Batches released from 22 July 2022 must carry a corrected label containing the required warning statement for activated charcoal.
Is it safe to continue using this medicine?
Yes, however, use of the medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Be aware that the labels for batch EYD07217E1 of 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, supply of the medicine without the warning statement stopped in July 2020. Therefore, the medicine is unlikely to pose an immediate risk to consumer health and safety.
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 provide information requested as part of the compliance review.
The TGA then required the sponsor to provide the requested information and correct an issue with the medicine. The sponsor provided the information and updated the label to include the warning statement for activated charcoal.
Additional information
This review was conducted as part of a targeted project

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