FDA · Drug recall
Hydro Pinapple Burn Max Health Thach Dua…
- Date
- Sept. 22, 2021
- Risk class
- Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
- Status
- Terminated
- Filed by
- Ebay Seller - John Nguyen
- 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
- Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
- Distribution pattern
- USA Nationwide
- Quantity
- 35 boxes
- Codes and lots
- All lots within expiry.
- Recall started
- Aug. 11, 2021
- Recall number
- D-0797-2021
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement report, recall number D-0797-2021. The agency record governs; check it and the company before acting.