NEI XIAO LUO LI WAN (Shen Neng Herbal Medicines Group Pty Ltd)
Product Name
NEI XIAO LUO LI WAN
ARTG
73118
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?
Do not take this medicine because it is past its expiry date
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
None
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 issued an educational letter to the sponsor. The sponsor was not required to respond but was expected to correct the minor issues. They cancelled the medicine and withdrew it from further supply.
The TGA then issued an educational letter to the sponsor. The sponsor was not required to respond but was expected to correct the minor issues. They cancelled the medicine and withdrew it from further supply.
Additional information
This review was conducted as part of a targeted project