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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description 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
Recall Number D-1330-2014
Classification Class I
Code Info All lots
Product Distributed Qty 311 pouches
Reason For Recall 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.

Event Detail

Event Id 65774
Product Type Drugs
Status Ongoing
Recalling Firm Herbal Give Care Llc
City Grand Prairie
State TX
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-19
Initial Firm Notification of Consignee or Public Press Release
Distribution Pattern Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.