FDA-Drug2014-05-28Class I
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
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
311 pouches
Manufactured in
1901 S Great Southwest Pkwy Ste 101, N/A, Grand Prairie, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1330-2014Don't want to check this manually?
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