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