Herbal Tea Recalled for Undeclared Sibutramine and Related Compounds
Herbal Give Care Llc is recalling Esbelin Siloutte Te herbal tea because it contains undeclared sibutramine and related compounds, making it an unapproved new drug.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Herbal Give Care Llc is recalling 311 pouches of Esbelin Siloutte Te, a herbal tea sold in gold foil/plastic zip-lock pouches. The product was manufactured in Mexico and distributed nationwide to distributors, with some units sold directly to consumers. All lots are affected.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Testing revealed the presence of undeclared sibutramine, N-Desmethylsibutramine, and N-di-Desmethylsibutramine. Sibutramine was previously removed from the U.S. market for safety reasons, which classifies these products as unapproved new drugs.
Consumers who possess this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea in a gold foil/plastic zip-lock pouch. Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7562684652553
- Manufacturer
- Herbal Give Care Llc
- Category
- Drug — Unapproved New Drug
- Affected units
- 311
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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Herbal Give Care Llc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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