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Recall Observatory FDA recall evidence

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

D-1330-2014

July 19, 2013

Class I

Product summary

Firm
Herbal Give Care Llc
Event
Event 65774
Status
Terminated
Classification
Class I
Quantity
311 pouches
Official record key
drug-enforcement:D-1330-2014

Official wording

Reason: 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.

Code information: All lots

Distribution pattern: Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.