Perdays Pregnancy Iron & Vitamin C (PERDAY'S HEALTH FUNCTIONAL FOOD (AU) PTY LTD)
Product Name
Perdays Pregnancy Iron & Vitamin C
ARTG details
Date of review outcome
Date of publication
Mar-2026
Outcome
Medicine continues to be permitted for supply.
Nine batches of this medicine (PDS3024, PDS3026, PDS3028, PDS3034, PDS3035, PDS3040, PDS3043, PDS3055, PBI10008) have been recalled by the sponsor due to the label not including a required warning statement. Batches released from 1 December 2025 must carry a corrected label.
Nine batches of this medicine (PDS3024, PDS3026, PDS3028, PDS3034, PDS3035, PDS3040, PDS3043, PDS3055, PBI10008) have been recalled by the sponsor due to the label not including a required warning statement. Batches released from 1 December 2025 must carry a corrected label.
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 this medicine is not for the treatment of iron deficiency conditions.
If you are pregnant, seek advice from a health practitioner if you have been taking this medicine for this purpose.
Be aware that vitamin supplements should not replace a balanced diet.
If you are pregnant, seek advice from a health practitioner if you have been taking this medicine for this purpose.
Be aware that vitamin supplements should not replace a balanced diet.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The website for this medicine contained a claim regarding helping prevent dietary iron deficiency. Claims related to iron supplementation during pregnancy have the potential to lead consumers to delay access to timely medical advice or treatment when required and may result in adverse outcomes.
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.
The sponsor removed this claim from the website, and the affected batches were recalled.
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.
The sponsor removed this claim from the website, and the affected batches were recalled.
Issues related to efficacy
The website for this medicine contained a claim regarding helping prevent dietary iron deficiency. This claim was not covered by the sponsor's certification that they held evidence to substantiate it.
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor recalled the affected batches of this medicine from the market and updated the label and website to correct the issues.
The TGA issued an infringement notice (https://www.tga.gov.au/news/media-releases/perdays-australia-issued-infringement-notice-alleged-unlawful-advertising-therapeutic-good) to the sponsor for advertising a therapeutic use that was not accepted as an indication for this medicine.
The TGA then issued an educational letter to the sponsor outlining the issues with this medicine.
The TGA issued an infringement notice (https://www.tga.gov.au/news/media-releases/perdays-australia-issued-infringement-notice-alleged-unlawful-advertising-therapeutic-good) to the sponsor for advertising a therapeutic use that was not accepted as an indication for this medicine.
The TGA then issued an educational letter to the sponsor outlining the issues with this medicine.