Consumers and health professionals are advised that SFI Australasia, in consultation with the TGA, has initiated a recall for one batch of Ellura capsules due to the presence of ethylene oxide.
Ellura is a listed medicine used to support urinary tract health.
The affected batch number is:
N0121301 (expiry 01/2024)
and it was first sold into the Australian market on 1 July 2021.
SFI Australasia is writing to all pharmacies and wholesalers who have purchased this product, advising to inspect stock immediately and quarantine units from the affected batch. All unsold units of the affected batch will be removed from the market.
What should I do?
If you or someone you care for is taking Ellura capsules, check the batch number displayed on the box.
If the box is from the affected batch, stop using the product and return it to the place of purchase for a refund.
If you have any questions or concerns, contact the SFI Australasia product support team on 1800 334 224 or your health professional.
What is ethylene oxide and what are the risks?
Ethylene oxide can be used in the manufacture of capsule shells and then be present in very small quantities in the finished medicine. We use a very conservative approach to set limits on these trace levels. Residual ethylene oxide in pharmaceutical products should not exceed 0.1 parts per million (ppm). SFI Australasia has identified ethylene oxide at concentrations of 170ppm in batch N0121301 of Ellura capsules.
Health concerns have been identified when people are exposed to ethylene oxide over prolonged periods.Hazards include gastric carcinoma and mutagenic and reproductive toxicity. However, if you follow the recommended dosage of Ellura capsules, the risk posed by ethylene oxide exposure is very low.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.
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.