Recalls / Class I
Class ID-371-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Affected lot / code info
- Lot 10032011, Exp 10/14
Why it was recalled
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.
Recalling firm
- Firm
- Bethel Nutritional Consulting, Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 599 W 190th St Ste 1, N/A, New York, New York 10040-3577
Distribution
- Quantity
- 9,121 bottles
- Distribution pattern
- Nationwide, Puerto Rico, and internet sales
Timeline
- Recall initiated
- 2013-08-05
- FDA classified
- 2013-12-18
- Posted by FDA
- 2013-12-25
- Terminated
- 2018-05-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-371-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.