DEEP LUNG SUPPORT (McBoben Group)
Product Name
DEEP LUNG SUPPORT
Sponsor
ARTG
285750
Date of review outcome
Date cancellation takes effect
Date of publication
Sep-2023
Outcome
Medicine is no longer permitted to be supplied. Batch 14524 of this medicine has been recalled by the sponsor due to the label not including a required warning statement.
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 Andrographis, which may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis) stop use and seek immediate medical attention.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to lung detoxification, lung health, promoting healthy breathing, assisting against smoke and pollution, relieving symptoms of cough, being an anti-virus formula, nourishing throat, lungs and respiratory tract, and relieving nasal congestion associated with upper respiratory irritations.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to lung detoxification, lung health, promoting healthy breathing, assisting against smoke and pollution, relieving symptoms of cough, being an anti-virus formula, nourishing throat, lungs and respiratory tract, and relieving nasal congestion associated with upper respiratory irritations.
Review scope
Targeted (See Additional Information below)
Information reviewed
ARTG Record, Labels
Issues related to safety
A batch of this medicine was missing the mandatory warning statement for herbal ingredient Andrographis paniculata, as set out under 'What actions should consumers take?' above. This warning statement is necessary to ensure the safe use of this medicine and to alert consumers to safety risks prior to taking this medicine. The affected batch was recalled and is unlikely to pose a further risk to consumers.
Issues related to efficacy
The label for this medicine contained claims specified in 'What action should consumers take?' above. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor recalled the affected batch, but did not sufficiently address all the issues. The TGA cancelled this medicine and withdrew permission for further supply.
Grounds for cancellation
The sponsor has refused or failed to comply with a condition to which the inclusion of the goods is subject (paragraph 30(2)(c) of the Act)
Additional information
This medicine was targeted to check its compliance with warning statement requirements related to Andrographis paniculata. Internal review requested by the sponsor confirmed cancellation decision.