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Type of Product	Medicine
TGA Recall Reference	RC-2022-RN-00275-1
Product Name/Description	Havyco Vy & Tea Barcode number: 8936125432063 Expiry dates: 01/06/2022 & 01/10/2022 ARTG not on register
Recall Action Level	Consumer
Recall Action Classification	Class II
Recall Action Commencement Date	3/03/2022
Responsible Entity	Unknown - For Recalls Unit use only
Reason/Issue	Vy & Tea Australia has become aware about the presence of undeclared substances phenolphthalein and sibutramine in the product Vy and Tea. Both the substances are classified as prescription only medicines. The health risk associated with this issue is 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. Phenolphthalein is a prescription-only substance and have concerns over its carcinogenicity with long term use. The product Vy & Tea has 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. No adverse events have been reported to date.
Recall Action	Recall
Recall Action Instructions	Vy and Tea are advising customers to stop using Vy and Tea immediately and return affected products.
Contact Information	0448 575757 - Vy and Tea