SOUTHPOLE OCEANKING DEEP OCEAN SHARK SQUALENE 1000MG (Australian Antarctic Ocean Bio-Technology Pty Ltd)
Product Name
SOUTHPOLE OCEANKING DEEP OCEAN SHARK SQUALENE 1000MG
Date of review outcome
Date of publication
Sep-20
Outcome
Medicine continues to be permitted for supply. Batches released from July 2020 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
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The medicine contains an ingredient derived from fish or fish products, and one that includes sulfites, neither of which were declared on the label.
Fish products and sulfites are required to be declared on the labels of medicines 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 occurences. 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.
Fish products and sulfites are required to be declared on the labels of medicines 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 occurences. 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 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’. The sponsor replaced stock in stores that did not include the warning statements on the label, with stock that does.