FDA Recall D-372-2014
Bethel Nutritional Consulting, Inc · New York, NY
Class I — life-threatening Terminated 1759 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
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 record
- Recall number
D-372-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide, Puerto Rico, and internet sales
- Recall initiated
- 2013-08-05
- Classified by FDA Center
- 2013-12-18
- FDA published
- 2013-12-25
- Terminated
- 2018-05-30
- Recalling firm
- Bethel Nutritional Consulting, Inc
- Firm location
- New York, NY