D-921-2013 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 4, 2013
- Initiation Date
- June 11, 2013
- Termination Date
- June 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,678 bottles
Product Description
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
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.
Distribution Pattern
Nationwide. Product was also available for sale via internet
Code Information
Lot #: 120514, EXP: 12/2014