Herbal Give Care Recalls Esbelder Fem Supplement for Undeclared Sibutramine
Herbal Give Care Llc is recalling Esbelder Fem Mezcla con L-Carnitina because it contains undeclared sibutramine, a drug removed from the U.S. market for safety reasons.
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 347 bottles of Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio, 30 capsule bottles. The product was manufactured in Mexico by Soluciones HGC S. de R.L. de C.V. and distributed nationwide to distributors, with some product sold directly to consumers.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and was found to contain 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 have purchased this product should stop using it and contact the recalling firm for further instructions. The recall covers all lots of the product.
The recalled product
- Product
- Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle, Hecho en Mexico: Soluciones HGC S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000251
- Manufacturer
- Herbal Give Care Llc
- Category
- Drug — Dietary Supplement
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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