drugs Class I Updated 2013-12-25

Bethel Nutritional Consulting, Inc recalls Bethel Advance (bitter orange, mulberry leaf, cassia seed ex

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot 10092011, Exp 2014
View official government recall

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