Recalls / Class I
Class ID-1330-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- All lots
Why it was recalled
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.
Recalling firm
- Firm
- Herbal Give Care Llc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1901 S Great Southwest Pkwy Ste 101, N/A, Grand Prairie, Texas 75051-3557
Distribution
- Quantity
- 311 pouches
- Distribution pattern
- Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.
Timeline
- Recall initiated
- 2013-07-19
- FDA classified
- 2014-05-20
- Posted by FDA
- 2014-05-28
- Terminated
- 2015-08-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1330-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.