D-0749-2021 Class I Ongoing
FDA drug recall D-0749-2021 was initiated by Qikmoov LLC on July 14, 2021 and is designated Class I. Reason for recall: Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine. The recall status is ongoing. Affected quantity: 591 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- August 11, 2021
- Initiation Date
- July 14, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 591 boxes
Product Description
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 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.
Code Information
Best By Date: 9/2021