FDA Recall D-921-2013
Bethel Nutritional Consulting, Inc · New York, NY
Class I — life-threatening Terminated 1842 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-921-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide. Product was also available for sale via internet
- Recall initiated
- 2013-06-11
- Classified by FDA Center
- 2013-08-23
- FDA published
- 2013-09-04
- Terminated
- 2018-06-27
- Recalling firm
- Bethel Nutritional Consulting, Inc
- Firm location
- New York, NY