Elektra Magnesium Cream (Elektra Life Pty Ltd)
Product Name
Elektra Magnesium Cream
Sponsor
ARTG
183096
Date of review outcome
Date of publication
Dec-22
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?
Do not use this medicine because it is past its expiry date. Seek advice from a suitably qualified health professional if you have been using this medicine while pregnant or trying to become pregnant.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The label of the medicine was missing the warning statements ‘Do not use if pregnant or likely to become pregnant’ and ‘Keep out of reach of children’. As such, women who are pregnant or likely to become pregnant may not be alerted to the fact that this medicine is not recommended for them prior to using the medicine. Leaving the medicine within reach of children may also cause harm if used incorrectly. The last batch of the medicine expired in July 2022 and consumers should not be taking expired medicines.
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 as a listed medicine. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with the medicine.
Additional information
This medicine was targeted to check its compliance with warning statement requirements related to use during pregnancy