FDA recall D-0749-2021

Qikmoov LLC · Class I · 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.

Reason for recall

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

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2021-07-14
Report date
2021-08-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Norwalk, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0749-2021