Hydro Pineapple Burn Max Health Supplement Recalled for Undeclared Sibutramine
Hydro Pineapple Burn Max Health supplement sachets are being recalled because they contain undeclared sibutramine and were marketed without FDA approval. The product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I drug recall for an unapproved drug containing an undeclared pharmaceutical ingredient (sibutramine). Per the rubric, FDA Class I recalls are scored at minimum 4 (Severe).
Plain-English summary
Hydro Pineapple Burn Max Health Thach Dua, a supplement product packaged in boxes containing 20g sachets (35 boxes total), is being recalled due to the presence of undeclared sibutramine. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Sibutramine is a pharmaceutical ingredient that requires FDA approval. The unapproved marketing and undeclared presence of this ingredient makes the product a Class I drug recall. All lots within expiry are affected.
The product, identified by UPC 8 936188 880108 and sold by eBay seller John Nguyen, was distributed nationwide in the USA. Consumers who have purchased this product should stop using it immediately and consult a healthcare provider if they have questions about their health.
The recalled product
- Product
- Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108
- Manufacturer
- Ebay Seller - John Nguyen
- Affected units
- 35
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
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