D-372-2014 Class I Terminated
FDA drug recall D-372-2014 was initiated by Bethel Nutritional Consulting, Inc on August 5, 2013 and is designated Class I. 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 ph… The recall status is terminated (terminated May 30, 2018). Affected quantity: 13,266 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 25, 2013
- Initiation Date
- August 5, 2013
- Termination Date
- May 30, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,266 bottles
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.
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.
Distribution Pattern
Nationwide, Puerto Rico, and internet sales
Code Information
Lot 10092011, Exp 2014