Essential Health Adults Gummies Multivitamin (Essence Group Pty Ltd)
Product Name
Essential Health Adults Gummies Multivitamin
Sponsor
ARTG
317163
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, based on the sponsor’s certification
What action should consumers take?
Be aware that the medicine’s expiry date may not be accurate when stored as directed on the label
Review scope
Targeted
Information reviewed
ARTG Record, Evidence, Labels, Manufacturing Documentation
Issues related to safety
The safety of the medicine was not assessed as part of this review
Issues related to efficacy
The sponsor did not hold sufficient information to support the shelf life of the medicine. The stability data was not relevant as it did not have the same active ingredients and storage conditions as the medicine.
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor cancelled the medicine and withdrew it from further supply.