FDA-Drug2014-05-28Class I
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
Herbal Give Care Llc
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.
Sold states
Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.
Affected count
54 bottles of 30 capsules each
Manufactured in
1901 S Great Southwest Pkwy Ste 101, N/A, Grand Prairie, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1331-2014Don't want to check this manually?
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