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Nordic Naturals Arctic Cod Liver Oil Capsules (Nordic Naturals Australasia Pty Ltd)

Product Name
Nordic Naturals Arctic Cod Liver Oil Capsules
Date of review outcome
Date of publication
Sep-22
Outcome
Medicine continues to be permitted for supply. Batches released from 31 March 2021 must carry a corrected label with the warning statements 'Contains fish/Contains fish products' and 'Contains sulfites'.
Is it safe to continue using this medicine?
Yes, however, use of the medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
The medicine contains fish products and sulfites. Consider whether the medicine is right for you if you have allergies or sensitivities to these substances. If you develop a reaction, discontinue use and consult a suitably qualified health practitioner.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
The medicine contains the herbal ingredients rosemary oil and lemon oil which may contain safrole and oxedrine respectively. These are potentially harmful substances. There are quantity restrictions in place for safrole and oxedrine to ensure the safe use of listed medicines. The sponsor did not have documentation to support their certification that the medicine complied with safety limits for safrole and oxedrine. However, subsequent testing indicated that the quantity of safrole and oxedrine in the medicine is within permissible limits and unlikely to pose a safety risk to consumers.
The medicine contains an ingredient derived from fish or fish products, and one that includes sulfites, which are required to be declared on the labels as they may cause adverse reactions in individuals with allergies or sensitivities to such substances. However, the presentation of the medicine makes it clear to consumers that the product is derived from fish products, and current data suggests that severe reactions to sulfites, such as anaphylaxis, are rare occurrences. In addition, the sponsor has removed all stock that did not include the label warning statements from stores. As such, the medicine is unlikely to pose an immediate risk to consumer health and safety
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA issued an educational letter to the sponsor reminding them of their regulatory responsibilities, and required the sponsor to correct the issues with the medicine. The sponsor updated the label to include the warning statements 'Contains fish/Contains fish products' and 'Contains sulfites'.
Additional information
This medicine was targeted to check its compliance in relation to quantity restrictions for the substance safrole

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