Recalls / Class I
Class ID-1333-2014
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
Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle, Hecho en Mexico: Soluciones HGC S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000251
- 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
- 347 bottles of 30 capsules each
- 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-1333-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.