Products found to contain undeclared medicines
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| Australia: Safety advisory: Tantra Jelly oral jelly satchels contain the undeclared substances sildenafil and tadalafil |
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Therapeutic Goods Administration (TGA) announces that it has tested a product labelled Tantra Jelly oral jelly satchels and found that the product contains the undeclared substances sildenafil and tadalafil.
Sildenafil and tadalafil may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol or heart disease are often prescribed nitrates. Sildenafil and tadalafil taken in combination with other medications can cause serious side effects. Consumers are advised that sildenafil and tadalafil is prescription-only substance in Australia. The supply of Tantra Jelly oral jelly satchels containing undisclosed sildenafil and tadalafil is illegal. Tantra Jelly oral jelly satchels have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.
Consumers are advised to stop using Tantra Jelly oral jelly satchels and take any remaining product to their local pharmacy for safe disposal. If they have any concerns arising from their use of this product, consult their health care practitioner.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-alerts/tantra-jelly
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by the United States Food and Drug Administration, and was posted on the Drug Office website on 11 Apr 2023.
Ends/Monday, Jan 29, 2024
Issued at HKT 15:30
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