Iron + (JSHealth Vitamins Pty Ltd)
Product Name
Iron +
Sponsor
ARTG
333766
Date of review outcome
Date of publication
Mar-23
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, follow the recommended actions below.
What action should consumers take?
Be aware that the label for this medicine is missing the warning statement 'Not for the treatment of iron deficiency conditions'. Seek advice from a medical practitioner if you have been taking this medicine for this purpose.
Review scope
Targeted
Information reviewed
ARTG Record, Labels
Issues related to safety
The label does not include the mandatory warning statement 'Not for the treatment of iron deficiency conditions'. As such, consumers may not be alerted to this safety risk prior to taking the medicine.
While this is unacceptable, the label includes 'vitamins and minerals can only be of assistance if dietary intake is inadequate' and 'If symptoms persist, talk to your health professional'. As such, the medicine is unlikely to pose an immediate risk to consumer health and safety.
While this is unacceptable, the label includes 'vitamins and minerals can only be of assistance if dietary intake is inadequate' and 'If symptoms persist, talk to your health professional'. 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 sponsor cancelled the medicine and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with the medicine.