Yes, based on the sponsor's certification. However, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
This medicine contains sulfites and soya bean products. Consider whether this medicine is right for you if you have allergies or sensitivities to these substances. If you develop a reaction, discontinue use and consult a suitably qualified health practitioner. The last batch of this medicine expired in November 2021 and consumers should not be taking expired medicines.
ARTG Record, Labels
Issues related to safety
The label for this medicine was missing the mandatory declaration for 'sulfites' and 'soya bean products'. Sulfites and soya bean products are required to be declared on the labels of medicines as they may cause adverse reactions in individuals with allergies or sensitivities to such substances. Whilst the undeclared presence of trace amounts of these substances may pose a safety risk for some consumers, current data suggests that severe adverse reactions due to trace residue of sulfites (such as anaphylaxis) and soya bean products are rare. Additionally, there is no stock of this medicine within expiry remaining in the marketplace. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of this medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor cancelled this medicine and withdrew it from further supply.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.