Zifam Krill Oil (Contract Manufacturing & Packaging Services Pty Ltd)
Product Name
Zifam Krill Oil
ARTG
266657
Date of review outcome
Date of publication
Sep-20
Outcome
Medicine is no longer permitted to be supplied
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. The last batch of the medicine expired in March 2020 and consumers should not be taking expired medicines.
Review scope
Targeted (for presence of seafood warning)
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The label for the medicine did not include either of the mandatory warning statements, ‘Derived from seafood’ or ‘Contains crustacean shellfish’. The website for the medicine did not include the required warning statements ‘This medicine may not be right for you. Read the warnings before purchase’, ‘Always read the label’ and ‘Derived from seafood’. 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
The TGA required the sponsor to correct the issues with the medicine. The sponsor cancelled the medicine and withdrew it from further supply.