Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 88
Summary
The FDA issued a Class I for Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 by Ebay Seller - John Nguyen. Reason: Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine.
Details
Source
Drug Recall
External ID
D-0797-2021
Action Date
2021-09-22
Status
Terminated
Category
drug
Product Description
Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108
Lot/Code Info: All lots within expiry.
Quantity Affected: 35 boxes
Reason for Recall
Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-11
Company
Houston, TX
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 25 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 (Ebay Seller - John Nguyen) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ebay Seller - John Nguyen have FDA actions?
This is the only FDA action we have on record for Ebay Seller - John Nguyen in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0797-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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