FDA Recall D-0749-2021

Qikmoov LLC · Norwalk, CA

Class I — life-threatening Ongoing 1765 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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.

Lot / code: Best By Date: 9/2021

Quantity: 591 boxes

Reason for recall

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

Recall record

Recall number: D-0749-2021
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
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.
Recall initiated: 2021-07-14
Classified by FDA Center: 2021-08-17
FDA published: 2021-08-11
Recalling firm: Qikmoov LLC
Firm location: Norwalk, CA

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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