FDA Recall D-0797-2021
Ebay Seller - John Nguyen · Houston, TX
Class I — life-threatening Terminated 796 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108
Reason for recall
Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
Recall record
- Recall number
D-0797-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- USA Nationwide
- Recall initiated
- 2021-08-11
- Classified by FDA Center
- 2021-09-14
- FDA published
- 2021-09-22
- Terminated
- 2023-10-16
- Recalling firm
- Ebay Seller - John Nguyen
- Firm location
- Houston, TX