FDA-Drug2013-12-25Class I
Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut) capsules, 400 mg, 30-count bottles, Distributed by: Bethel, Inc., Tel: (212) 568-5330, UPC 1 60126 41750 9.
Bethel Nutritional Consulting, Inc
Hazard
Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Sold states
Nationwide, Puerto Rico, and internet sales
Affected count
13,266 bottles
Manufactured in
599 W 190th St Ste 1, N/A, New York, NY, United States
Products
Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut) capsules, 400 mg, 30-count bottles, Distributed by: Bethel, Inc., Tel: (212) 568-5330, UPC 1 60126 41750 9.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-372-2014Don't want to check this manually?
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