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Ausfebis (Pharmametics Products A Division of Max Biocare Pty Ltd)
Product Name
Ausfebis
ARTG details
- 321405
Date of review outcome
Date of publication
Dec-2024
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, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Not for the treatment of iron deficiency conditions. Seek advice from a medical practitioner if you have been taking this medicine for this purpose.
The last batch of this medicine supplied expired in April 2024. Do not take this medicine as it has passed its expiry date.
The last batch of this medicine supplied expired in April 2024. Do not take this medicine as it has passed its expiry date.
Review scope
Targeted
Information reviewed
ARTG Record, Labels
Issues related to safety
The label for this medicine was missing the mandatory warning statement for the ingredient iron, as set out under 'What action should consumers take?' above. This warning statement is necessary to ensure the safe use of this medicine and to alert consumers to safety risks prior to taking it.
While this omission is unacceptable, the last batch of this medicine expired in April 2024. Additionally, this medicine was never supplied in Australia. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
While this omission is unacceptable, the last batch of this medicine expired in April 2024. Additionally, this medicine was never supplied in Australia. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of this medicine was not assessed as part of this review
Actions taken during the review
The sponsor cancelled this medicine and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with this medicine.