Cellife AMPK Fatburst (Cellife Health Products Pty Ltd)
Product Name
Cellife AMPK Fatburst
Sponsor
Date of review outcome
Date of publication
Sep-2024
Outcome
Medicine continues to be permitted for supply. One batch of this medicine (07258) has been recalled by the sponsor due to the label not including a required warning statement. Batches released from 8 April 2024 must carry a corrected label.
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
This medicine contains Oyster Shell (Mollusc), which may cause allergic reactions in some people. If you develop a reaction, discontinue use and consult a medical practitioner.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels
Issues related to safety
The labels for this medicine were missing the required warning statement for mollusc-derived ingredients. Mollusc-derived ingredients are required to be declared on the labels of medicines as they may cause adverse reactions in individuals with allergies or sensitivities to such substances. However, the affected batches were recalled and are unlikely to pose a further risk to consumer health and safety.
Issues related to efficacy
The efficacy of this medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issue with this medicine. The sponsor updated the label to correct the issue. The sponsor recalled the affected batch of this medicine from the market.
Additional information
This medicine was targeted to check its compliance with warning statement requirements related to mollusc-derived ingredients