FDAFDA · Food and drugs·Recall number D-372-2014
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.
Published December 25, 2013 · Recall initiated: August 5, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Bethel Nutritional Consulting, Inc
- Distributor
- Nationwide, Puerto Rico, and internet sales
- Lot
- Lot 10092011, Exp 2014
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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