Recalls / Class I

Class ID-372-2014

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

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.

Affected lot / code info: Lot 10092011, Exp 2014

Why it was recalled

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.

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: 13,266 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-372-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.