FDA Recall D-371-2014
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
Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powder, alfalfa, mulberry leaf, guarana, spirulina) capsules, 400 mg, 30-count bottle, Distributed by: Bethel, Inc., Tel: (212) 568-5330.
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and phenolphthalein. 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-371-2014- 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