PainAway Arthritis Pain Relief Cream (365 Health Australia Pty Ltd)
Product Name
PainAway Arthritis Pain Relief Cream
Sponsor
ARTG
266122
Date of review outcome
Date of publication
Dec-21
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?
Do not use this medicine because it is past its expiry date
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Laboratory Results, Manufacturing Documentation
Issues related to safety
The medicine contains the ingredient rosemary oil which may contain safrole, a potentially harmful substance. There are quantity restrictions in place for safrole to ensure the safe use of listed medicines. The sponsor did not have documentation to support their certification that the medicine complied with safety limits for safrole. Subsequent testing indicated that the quantity of safrole in the medicine is within permissible limits and unlikely to pose a safety risk to consumers.
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.
Additional information
This medicine was targeted to check its compliance in relation to quantity restrictions for the substance safrole