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G Trim (Contract Manufacturing & Packaging Services Pty Ltd)

Product Name
G Trim
Date of review outcome
Date of publication
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, follow the recommended actions below.
What action should consumers take?
This medicine contains 111 mg total caffeine per dosage unit. A cup of instant coffee contains approximately 80 mg of caffeine. Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding. Limit the use of caffeine-containing products (including tea and coffee) when taking this product. Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines.
A sachet of this medicine contains 111 mg total caffeine. Consumers should not take more than 100 mg total caffeine within a 3 hour period. Seek advice from a healthcare practitioner if you have been taking this medicine.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels
Issues related to safety
The ARTG record and label this medicine was missing the mandatory warning statements for caffeine, as set out under 'What action should consumers take'. These warning statements are necessary to ensure the safe use of this medicine and to alert consumers to safety risks prior to taking thise medicine.
This medicine contains an amount of total caffeine in a sachet that exceeds the permitted limit of maximum single dose for listed medicines. Ingredient limits for listed medicines are in place to ensure their safety. While the omission of the warning statment and exceeding the ingredient limit is unacceptable, this medicine was not supplied in Australia, and current data indicated the amount of total caffeine in this medicine is unlikely to pose an immediate risk to consumer health and safety.
In addition, this medicine has not been manufactured since June 2020 and no stock remains with the sponsor and their distributors.
Issues related to efficacy
The efficacy of this medicine was not assessed as part of this review
Actions taken during the review
The sponsor cancelled this medicine and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with this medicine.
Additional information
This medicine was targeted to check its compliance in relation to quantity restrictions and warning requirements for the substance caffeine

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