Mega B High Potency (Nutrivital Pty Ltd)
Product Name
Mega B High Potency
Sponsor
ARTG
141242
Date of review outcome
Date of publication
Jun-20
Outcome
Medicine continues to be permitted for supply. Batches released from 13 March 2020 must carry a corrected label with the words ‘healthcare practitioner’ rather than ‘healthcare professional’ in the required warning statement for vitamin B6.
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Stop taking this medicine if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The label included an incorrect version of the mandatory warning statement ‘Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6]’. Instead of the words 'healthcare practitioner' the words 'healthcare professional' were used.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
TGA issued an educational letter to the sponsor. The sponsor updated the label of the medicine to correct the identified issue.