• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

  • Print
  • Share
  • E-mail
-

Product Detail

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
Recall Number D-1331-2014
Classification Class I
Code Info All lots
Product Distributed Qty 54 bottles of 30 capsules each
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.
-
-