Berocca Boost with Guarana oral solution (Bayer Australia Ltd)
Product Name
Berocca Boost with Guarana oral solution
Sponsor
ARTG
232442
Date of review outcome
Date of publication
Mar-23
Outcome
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 75 mg total caffeine per dosage unit. A cup of instant coffee contains approximately 80 mg of caffeine. Consider whether the medicine is right for you if you are pregnant or breastfeeding, as caffeine intake of more than 200 mg per day is not recommended during pregnancy or breastfeeding.
The last batch of the medicine supplied expired in May 2022. Do not take this medicine as it is past its expiry date.
The last batch of the medicine supplied expired in May 2022. Do not take this medicine as it is past its expiry date.
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 statements for caffeine as set out under 'What actions should consumers take'. As such, consumers may not be alerted to these safety risks prior to taking the medicine.
However, current data indicates that the amount of caffeine in the medicine is unlikely to pose an immediate risk to consumer health and safety.
In addition, the last batch of the medicine supplied expired in May 2022.
However, current data indicates that the amount of caffeine in the medicine is unlikely to pose an immediate risk to consumer health and safety.
In addition, the last batch of the medicine supplied expired in May 2022.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
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.
Additional information
This medicine was targeted to check its compliance in relation to quantity restrictions and warning requirements for the substance caffeine