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Recall Observatory FDA recall evidence

Drug product

Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured by Havyco No. 45, Group 1, National Highway 14, Son Hiep Hamlet, Tho Son Commune, Bu Dang District, Binh Phuoc Province, Vietnam, Website: trathaomocgiamcan.com.

D-0749-2021

July 14, 2021

Class I

Product summary

Firm
Qikmoov LLC
Event
Event 88280
Status
Ongoing
Classification
Class I
Quantity
591 boxes
Official record key
drug-enforcement:D-0749-2021

Official wording

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.

Code information: Best By Date: 9/2021

Distribution pattern: Distribution Nationwide in the USA via the internet and to the following countries Brazil, Canada, Germany, France, Hong Kong, Italy, Sweden, Switzerland, Thailand, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.