D-1331-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 28, 2014
- Initiation Date
- July 19, 2013
- Termination Date
- August 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54 bottles of 30 capsules each
Product Description
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
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.
Distribution Pattern
Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.
Code Information
All lots