What are the defects?
The product contains the undeclared substances phenolphthalein and sibutramine.
The products were supplied without an active Australian Registry for Therapeutic Goods (ARTG) registration.
What are the hazards?
The use of undeclared substances may be harmful.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. The product can be dangerous when used with other medications.
Phenolphthalein was withdrawn from sale in many markets in the late 1990s due to concerns it may cause an increased risk of cancer with long term use.
What should consumers do?
Consumers should immediately stop using this product and return all remaining products to the place of purchase for a full refund.
For further information, contact Vy & Tea Australia by phone on 03 9703 1010, by email at email@example.com or visit the TGA website at https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00275-1