Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured
Summary
The FDA issued a Class I for Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0 by Qikmoov LLC. Reason: Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine..
Details
Source
Drug Recall
External ID
D-0749-2021
Action Date
2021-08-11
Status
Ongoing
Category
drug
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.
Lot/Code Info: Best By Date: 9/2021
Quantity Affected: 591 boxes
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-14
Company
Norwalk, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 21 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Qikmoov LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Qikmoov LLC have FDA actions?
This is the only FDA action we have on record for Qikmoov LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0749-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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