Herbal Give Care Llc recalls Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico Por: Herbal Give Care, Av Independencia #
Recalled May 28, 2014 · FDA recall D-1331-2014 · 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
54 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
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
Manufacturer(s)
Herbal Give Care Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →