Antarctic Red Krill Oil 500mg soft gelatin capsule (Australian Antarctic Ocean Bio-Technology Pty Ltd)
Product Name
Antarctic Red Krill Oil 500mg soft gelatin capsule
ARTG
202639
Date of review outcome
Date of publication
Sep-20
Outcome
Medicine continues to be permitted for supply
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?
This medicine contains crustacean shellfish. Consider whether the medicine is right for you if you have allergies or sensitivities to this substance. If you develop a reaction, discontinue use and consult a suitably qualified health practitioner.
Review scope
Targeted (for presence of seafood warning)
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The website of the medicine, did not include the warning statement, ‘Derived from seafood’ or ‘Contains crustacean shellfish’. As such, consumers may not be alerted to the safety risks prior to taking the medicine. While this is unacceptable, the name of the medicine includes the animal source of the ingredient, and the label contains the seafood allergy warning statement. Therefore, 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 website to include the seafood warning statement.