FDA Recall D-1330-2014
Herbal Give Care Llc · Grand Prairie, TX
Class I — life-threatening Terminated 763 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
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.
Recall record
- Recall number
D-1330-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.
- Recall initiated
- 2013-07-19
- Classified by FDA Center
- 2014-05-20
- FDA published
- 2014-05-28
- Terminated
- 2015-08-21
- Recalling firm
- Herbal Give Care Llc
- Firm location
- Grand Prairie, TX