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.
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
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1330-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 19, 2013
- FDA report date
- May 28, 2014
- Quantity
- 311 pouches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Herbal Give Care Llc
Original FDA data
Every field from FDA enforcement report D-1330-2014, exactly as published.
Show all FDA fields
- City
- Grand Prairie
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 65774
- Address
- 1901 S Great Southwest Pkwy Ste 101
- Code information
- All lots
- Postal code
- 75051-3557
- Report date
- May 28, 2014
- Product type
- Drugs
- Recall number
- D-1330-2014
- Classification
- Class I
- Recalling firm
- Herbal Give Care Llc
- Product quantity
- 311 pouches
- Termination date
- Aug 21, 2015
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.
- Recall initiation date
- Jul 19, 2013
- Initial firm notification
- Press Release
- Center classification date
- May 20, 2014