Status
Terminated
Drug Enforcement D-372-2014
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.
Classification
Class I
Report Date
December 25, 2013
Termination Date
May 30, 2018
Product Information
- Product description
- 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.
- Product quantity
- 13,266 bottles
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide, Puerto Rico, and internet sales
Location & Firm
- Recalling firm
- Bethel Nutritional Consulting, Inc
- Address
-
599 W 190th St Ste 1, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-372-2014
- Event ID
- 65894
- Recall initiation date
- August 5, 2013
- Center classification date
- December 18, 2013
- Code info
- Lot 10092011, Exp 2014
- More code info
- —