Rapid Recovery (Phoenix Pharmaceuticals Australia)
Product Name
Rapid Recovery
ARTG
297954
Date of review outcome
Date cancellation takes effect
Date of publication
Mar-21
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?
Consider whether the medicine is right for you given that claims related to hangover relief were not substantiated by the sponsor.Be aware that consumption of this medicine is not a substitute for responsible drinking or for reducing the consumption of alcohol.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
The label for the medicine may promote its use as a substitute for responsible drinking, which is inconsistent with the public health campaigns about the responsible drinking of alcohol and that minimising alcohol intake is the best way of reducing alcohol-related harm. While advertising of this nature is unacceptable, it is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The sponsor did not hold sufficient evidence to support claims related to hangover relief. The limitations with the evidence included that the active ingredients, dosages, usage instructions, duration and frequency of dose described in the evidence were inconsistent with those for the medicine.
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor did not provide additional information to address the issues. The TGA cancelled the medicine and withdrew permission for further supply.
Grounds for cancellation
The certification under paragraph 26A(2)(ja) is incorrect (paragraph 30(2)(ba) of the Act).The presentation of the listed goods is unacceptable (paragraph 30(2)(aa) of the Act).The goods do not conform to a requirement relating to advertising applicable to the goods under Part 5-1 or the regulations (paragraph 30(2)(ea) of the Act).
Additional information
This medicine was targeted to check its compliance in relation to hangover claims