The Recall Desk

FDA (Drugs) recall action 65774

Herbal Give Care Llc recalled 5 products on 2014-05-28

The FDA (Drugs) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2014-05-28
Critical
5
Units
311

Why these products were recalled

Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • CriticalFDA (Drugs)··2014-05-28

    Herbal Give Care Recalls Esbelder Siloutte Supplement for Undeclared Sibutramine

    Herbal Give Care is recalling Esbelder Siloutte dietary supplements because they contain undeclared sibutramine, a drug removed from the U.S. market for safety reasons.

    Product
    Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000268
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2014-05-28

    Esbelder Man Herbal Blend Recalled for Undeclared Sibutramine

    Herbal Give Care Llc is recalling Esbelder Man Herbal Blend because it contains undeclared sibutramine, a drug removed from the U.S. market for safety reasons.

    Product
    Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bottle, Made in Mexico: Soluciones S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000275
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2014-05-28

    Esbelin Siloutte Mezcal Herbal Recalled for Undeclared Sibutramine

    Herbal Give Care Llc is recalling Esbelin Siloutte Mezcal Herbal because it contains undeclared sibutramine, a drug removed from the U.S. market for safety reasons.

    Product
    Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle, Hecho En Mexico Por: Soluciones HGC S. de R.L. de C.V. Av. Independicia #1016 Frac. La Rinconada Aguascalientes, Ags. Mex C.P. 20136, UPC 7502011000060
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2014-05-28

    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.

    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
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2014-05-28

    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.

    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
    Category
    Distribution
    0 states