Herbal Give Care Llc recalls Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle, Hecho En Mexico Por: Solucion
Recalled May 28, 2014 · FDA recall D-1329-2014 · Herbal Give Care
Hazard
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. · FDA Class I
Units
1053 bottles of 30 capsules each
Sold at
Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.
Description
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.
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
Manufacturer(s)
Herbal Give Care Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →