Recalls / Class I
Class ID-921-2013
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 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
- Affected lot / code info
- Lot #: 120514, EXP: 12/2014
Why it was recalled
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.
Recalling firm
- Firm
- Bethel Nutritional Consulting, Inc
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 599 W 190th St Ste 1, New York, New York 10040-3577
Distribution
- Quantity
- 18,678 bottles
- Distribution pattern
- Nationwide. Product was also available for sale via internet
Timeline
- Recall initiated
- 2013-06-11
- FDA classified
- 2013-08-23
- Posted by FDA
- 2013-09-04
- Terminated
- 2018-06-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-921-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.