Status
Terminated
Drug Enforcement D-921-2013
Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug.
Classification
Class I
Report Date
September 4, 2013
Termination Date
June 27, 2018
Product Information
- Product description
- Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
- Product quantity
- 18,678 bottles
- Reason for recall
- Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide. Product was also available for sale via internet
Location & Firm
- Recalling firm
- Bethel Nutritional Consulting, Inc
- Address
-
599 W 190th St Ste 1
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-921-2013
- Event ID
- 65441
- Recall initiation date
- June 11, 2013
- Center classification date
- August 23, 2013
- Code info
- Lot #: 120514, EXP: 12/2014
- More code info
- —