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Database of TGA listed medicine compliance review results

31 March 2020

Important information about this database

Safety alerts

When serious safety or quality issues are identified with therapeutic goods, this information and any recommendations are posted immediately on the Safety information pages of the TGA website.

Listed medicines are included on the Australian Register of Therapeutic Goods (ARTG) without undergoing pre-market evaluation by TGA. This relies on them satisfying certain criteria to ensure they are low risk and the sponsor certifying that their medicine meets all of the requirements of the Therapeutic Goods Act 1989.

To monitor the safety, quality and efficacy of listed medicines and ensure they meet all requirements once they are on the market, each year the TGA conducts listed medicine compliance reviews on a proportion of those on the ARTG.

If during a compliance review, a medicine is found to not comply with regulatory requirements, the TGA will notify the sponsor and take action according to the risk posed by the medicine to the consumer. The sponsor may be required to resolve the identified issues (such as update their listing or medicine labels) to bring the listed medicine into compliance. In some cases, the medicine may not to be cancelled from the ARTG, meaning that it can no longer be lawfully supplied to the consumer. Sponsors may also respond with further information to refute conclusions derived during the compliance of their medicine.

This database makes information publically available about the results of TGA's compliance reviews of individual listed medicines. The information contained within the database will assist consumers to make an informed choice about whether a specific listed medicine is safe and does what it says it does, as well as what actions the consumer is recommended to take in response to the findings of the review.

Descriptions of identified issues are provided if they relate to the safety and efficacy of a medicine. Details about minor issues, such as those of an administrative nature, are not provided.

Publication of results only occurs once the compliance review has been concluded, after sponsor has had the opportunity to consider our findings and actions have been undertaken to address any identified issues.

Results are released quarterly.

More information about the publication of compliance review results and this database is provided for sponsors on the post-market compliance reviews web page.

Brief descriptions of the information presented in this database are included below.

ARTG ID: The unique identification code of a product included in the Australian Register of Therapeutic Goods (ARTG). The ARTG ID for listed medicines starts with an 'AUST' and is followed by an 'L' and a sequence of numbers. The ARTG number is displayed on a medicine/s main label.

Review outcome: Indicates whether the medicine is still permitted to be supplied following the compliance review due to whether it remains on the ARTG or not. This may include information on any corrective action taken by sponsors to address identified issues so that the medicine can continue to be included on the ARTG and supplied.

If the review outcome states that a medicine is 'no longer permitted to be supplied' this does not necessarily mean that there were issues with a particular medicine or that it is unsafe to continue using. A sponsor may voluntarily choose to stop supplying and marketing their medicine to consumers and cancel it from the ARTG. If this occurs, the outcome of the review will reflect that the medicine is no longer permitted for supply.

Is it safe to continue using this medicine?: This is indicated by a 'yes' or 'no', with specific directions provided as required.

The database indicates whether the medicine is safe based only on the assessment performed and information reviewed by the TGA at a point in time. The TGA may not assess the safety of an individual product during a compliance review. This may occur for various reasons including when the safety of the product was not a focus of the review or the sponsor chooses to cease the supply or marketing of a particular product during a compliance review. As Listed medicines must meet certain low risk criteria and sponsors must certify that their medicine is safe for use before they supply it, it is assumed to be safe to continue using the medicine based on the sponsor's certification despite the safety of the medicine having not been reviewed by the TGA.

What action should consumers take?: A summary of any recommended actions for consumers if they have taken or intend to take the medicine.

Sponsor: The sponsor of a product refers to the sponsor at the time the product was reviewed by the TGA. The current sponsor for the product may have changed in the time since the product was reviewed. The current sponsor of a listed medicine product is displayed in the ARTG.

How was this medicine selected for review?: A listed medicine may be selected randomly or be targeted for a review. Further information is provided at: Listed medicines compliance reviews.

Information reviewed: The information the TGA evaluated during the compliance review to determine whether the medicine met the relevant legal requirements. The type of information reviewed can include: the ARTG record of the medicine; labels; advertising; manufacturing documentation; scientific or traditional evidence supporting what the medicine claims to do; laboratory testing results. A compliance review can evaluate some or all of this information.

Issues related to safety: A summary of any issues identified during the compliance review that:

  • have the potential or are likely to affect consumer safety
  • are breaches of legal requirements that are in place to ensure the low-risk status of listed medicines, even if they are unlikely to pose a significant risk to consumer health and safety

Issues related to efficacy: A summary of any issues identified during the compliance review that may, or do, affect product efficacy (that the medicine does what it says it will do).

Actions taken during the review: A summary of the actions that the TGA and the sponsor took during the compliance review to address any issues identified by the TGA, for example: TGA requiring the sponsor to correct the identified issues with their medicine.

Cancellation effective date (if applicable): If a listed medicine is cancelled from the ARTG by the TGA following a compliance review, the date the medicine was no longer listed on the ARTG. Where a medicine is cancelled from the ARTG, it cannot be supplied or marketed by the sponsor.

Date of review outcome/conclusion: The date the compliance review was closed by the TGA, which is after we consider a sponsor's submissions and any actions they took to rectify any identified issues.

Publication date: The date the compliance review information was published in the database.

Decision status (if applicable): If a listed medicine is cancelled from the ARTG by the TGA following a compliance review but this decision is later appealed and the decision to cancel is overturned.

Additional information (if applicable): Any other relevant information about the medicine.

For further information, please contact Complementary Medicines and OTC Medicines Branch via phone on 1800 020 653 or via email at complementary.medicines@health.gov.au.

Disclaimer about the release of information in this database

While reasonable care is taken to ensure that the information included in the database is an accurate record of the results and outcomes of TGA's listed medicines compliance reviews, the TGA does not guarantee or warrant the accuracy, reliability, completeness or currency of the information or its usefulness in achieving any purpose.

To the fullest extent permitted by law, including but not limited to section 61A of the Therapeutic Goods Act 1989, the TGA will not be liable for any loss, damage, cost or expense incurred in or arising by reason of any person relying on this information.

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Compliance review results

3580 (Kaiser Pharmaceutical) Dang Gui Yin Zi (Tangkuei & Tribulus Combination)

Date of review outcome: 10 Mar 2020

Publication date: Mar-2020

ARTG ID: 219954

Review outcome:

Medicine continues to be permitted for supply. Batches released from 30 October 2019 must carry a correct Fallopia Multiflora warning statement on the medicine label.

Is it safe to continue using this medicine?

Yes, if you follow the recommended actions below

What action should consumers take?

Take note of the warning statement 'Warning: Fallopia Multiflora may harm the liver in some people. Use under the supervision of a healthcare professional'.

Sponsor

Great Grand Care Pty Ltd

How was this medicine selected for review?

Targeted

Information reviewed

ARTG Record, Labels

Issues related to safety

The label had an incorrect version of the warning statement 'Warning: Fallopia Multiflora may harm the liver in some people. Use under the supervision of a healthcare professional', in that the word 'Warning:' was missing. As such, consumers may not be alerted to these safety risks prior to taking the medicine, which may lead to adverse outcomes.

Issues related to efficacy

The efficacy of the medicine was not assessed as part of this review

Actions taken during the review

TGA required the sponsor to correct the issues with the medicine. The sponsor updated the label to include the correct version of the warning statement.

BioSource Concentrated Krill Oil 1000mg Antioxidants + Omega 3 softgel capsules

Date of review outcome: 13 Feb 2020

Publication date: Mar-2020

ARTG ID: 204328

Review 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?

Do not take this medicine because it is past its expiry date

Sponsor

Australian Pharmaceutical Industries Pty Ltd

How was this medicine selected for review?

Targeted (for presence of seafood warning)

Information reviewed

None

Issues related to safety

The safety of the medicine was not assessed as part of this review

Issues related to efficacy

The efficacy of the medicine was not assessed as part of this review

Actions taken during the review

The sponsor cancelled the medicine and withdrew it from further supply
The sponsor cancelled the medicine because it is no longer marketed in Australia

BioSource Concentrated Krill Oil 500mg Antioxidants + Omega 3 softgel capsules

Date of review outcome: 13 Feb 2020

Publication date: Mar-2020

ARTG ID: 204369

Review 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?

Do not take this medicine because it is past its expiry date

Sponsor

Australian Pharmaceutical Industries Pty Ltd

How was this medicine selected for review?

Targeted (for presence of seafood warning)

Information reviewed

None

Issues related to safety

The safety of the medicine was not assessed as part of this review

Issues related to efficacy

The efficacy of the medicine was not assessed as part of this review

Actions taken during the review

The sponsor cancelled the medicine and withdrew it from further supply
The sponsor cancelled the medicine because it is no longer marketed in Australia

BioSource Krill Oil 1000mg

Date of review outcome: 12 Dec 2019

Publication date: Mar-2020

ARTG ID: 316277

Review outcome:

Medicine continues to be permitted for supply

Is it safe to continue using this medicine?

Yes

What action should consumers take?

None

Sponsor

Soul Pattinson Manufacturing Pty Ltd

How was this medicine selected for review?

Targeted (for presence of seafood warning)

Information reviewed

ARTG Record, Labels, Website

Issues related to safety

None

Issues related to efficacy

The efficacy of the medicine was not assessed as part of this review

Actions taken during the review

None

Caresence 3C II

Date of review outcome: 13 Feb 2020

Publication date: Mar-2020

ARTG ID: 286707

Review outcome:

Medicine continues to be permitted for supply

Is it safe to continue using this medicine?

Yes

What action should consumers take?

Consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to helping increase energy.

Sponsor

3C International Pty Ltd

How was this medicine selected for review?

Random

Information reviewed

ARTG Record, Labels, Manufacturing Documentation, Website

Issues related to safety

None

Issues related to efficacy

The website claimed that the medicine 'may help increase energy'. The sponsor did not certify that they hold evidence to substantiate this claim.

Actions taken during the review

TGA required the sponsor to correct the issues with the medicine. The sponsor removed the claim from the website.

Caruso's Kids Eye Care

Date of review outcome: 2 Jan 2020

Publication date: Mar-2020

ARTG ID: 278173

Review outcome:

Medicine is no longer permitted to be supplied

Is it safe to continue using this medicine?

Yes

What action should consumers take?

Consider whether the medicine is right for you based on particular claims for the medicine being unable to be substantiated by the sponsor. These claims are related to optimal motor skill and visual acuity development, effects on cellular membranes and neurotransmission, learning and behaviour, blue light protection, protection from eye damage, assistance with eye strain and fatigue, improvements in glare recovery and contrast sensitivity, protection of the brain, macula, retina, lens and associated tissue, the improvement of macula pigment density, mood maintenance, antioxidant activity, reduction in cellular damage, improvements or enhancements at the cellular level, the support of macula and retina health, brain and nervous system development and maintenance, effects on rod vision and eye development and function.

Sponsor

Caruso's Natural Health Pty Ltd

How was this medicine selected for review?

Random

Information reviewed

ARTG Record, Evidence, Labels, Manufacturing Documentation, Website

Issues related to safety

None

Issues related to efficacy

The sponsor did not hold sufficient evidence to support the advertised claims detailed in 'What action should consumers take?' above. The evidence held by the sponsor were either not relevant to or did not support the claims. The dosages and dosage forms of ingredients in the evidence provided were not applicable to the medicine. The populations described in the evidence (adults) were not applicable to the target population of the medicine (children).

Actions taken during the review

TGA required the sponsor to correct the issues with the medicine. The sponsor provided additional evidence and updated the label of the medicine, website and ARTG listing to remove some of the unsupported claims. TGA cancelled the medicine and moved to withdraw permission for further supply. The sponsor cancelled the medicine and withdrew it from further supply prior to TGA's cancellation taking effect.

Elevit Morning Sickness Relief

Date of review outcome: 26 Feb 2020

Publication date: Mar-2020

ARTG ID: 199826

Review outcome:

Medicine continues to be permitted for supply. Batches released after 25 October 2019 must carry a correct vitamin B6 warning statement on the medicine label.

Is it safe to continue using this medicine?

Yes, if you follow the recommended actions below

What action should consumers take?

Stop taking this medicine if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible, especially if you are taking multiple medicines containing vitamin B6.

Sponsor

Bayer Australia Ltd

How was this medicine selected for review?

Targeted

Information reviewed

ARTG Record, Labels

Issues related to safety

The label had an incorrect version of the warning statement 'Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6]', in that the statement 'Contains vitamin B6' was missing. These symptoms may be signs of nerve damage in some individuals as a result of vitamin B6 intake. It is important to help consumers link these symptoms to medicines containing vitamin B6, especially when taking medicines with multiple ingredients.

Issues related to efficacy

The efficacy of the medicine was not assessed as part of this review

Actions taken during the review

TGA required the sponsor to correct the issue with the medicine. The sponsor updated the label to include the correct warning statement.

GNC Ultra Mega Gold without iron and iodine

Date of review outcome: 14 Jan 2020

Cancellation effective date: 14 Feb 2020

Publication date: Mar-2020

ARTG ID: 196639

Review outcome:

Medicine is no longer permitted to be supplied

Is it safe to continue using this medicine?

Yes, based on the sponsor's certification

What action should consumers take?

None

Sponsor

Fit Retail Australia Pty Ltd

How was this medicine selected for review?

Targeted

Information reviewed

None

Issues related to safety

The safety of the medicine was not assessed as part of this review

Issues related to efficacy

The efficacy of the medicine was not assessed as part of this review

Actions taken during the review

TGA cancelled the medicine and withdrew permission for further supply as the sponsor did not provide the requested information
The sponsor failed to comply within 20 working days after a notice was given under section 31 requiring it to provide information or documents about the certifications made in relation to the goods.

GNC Women's Ultra Mega

Date of review outcome: 14 Jan 2020

Cancellation effective date: 14 Feb 2020

Publication date: Mar-2020

ARTG ID: 197526

Review outcome:

Medicine is no longer permitted to be supplied

Is it safe to continue using this medicine?

Yes, based on the sponsor's certification

What action should consumers take?

None

Sponsor

Fit Retail Australia Pty Ltd

How was this medicine selected for review?

Targeted

Information reviewed

None

Issues related to safety

The safety of the medicine was not assessed as part of this review

Issues related to efficacy

The efficacy of the medicine was not assessed as part of this review

Actions taken during the review

TGA cancelled the medicine and withdrew permission for further supply as the sponsor did not provide the requested information
The sponsor failed to comply within 20 working days after a notice was given under section 31 requiring it to provide information or documents about the certifications made in relation to the goods.

GNC Women's Ultra Mega

Date of review outcome: 14 Jan 2020

Cancellation effective date: 14 Feb 2020

Publication date: Mar-2020

ARTG ID: 283643

Review outcome:

Medicine is no longer permitted to be supplied

Is it safe to continue using this medicine?

Yes, based on the sponsor's certification

What action should consumers take?

None

Sponsor

Fit Retail Australia Pty Ltd

How was this medicine selected for review?

Targeted

Information reviewed

None

Issues related to safety

The safety of the medicine was not assessed as part of this review

Issues related to efficacy

The efficacy of the medicine was not assessed as part of this review

Actions taken during the review

TGA cancelled the medicine and withdrew permission for further supply as the sponsor did not provide the requested information
The sponsor failed to comply within 20 working days after a notice was given under section 31 requiring it to provide information or documents about the certifications made in relation to the goods.

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