FDA-Drug2014-05-28Class I

Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bottle, Made in Mexico: Soluciones S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000275

Herbal Give Care Llc
Hazard

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.

Sold states
Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.
Affected count
195 bottles of 30 capsules each
Manufactured in
1901 S Great Southwest Pkwy Ste 101, N/A, Grand Prairie, TX, United States
Products
Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bottle, Made in Mexico: Soluciones S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000275

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1332-2014

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