FDAFDA · Food and drugs·Recall number D-921-2013
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
Published September 4, 2013 · Recall initiated: June 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Bethel Nutritional Consulting, Inc
- Distributor
- Nationwide. Product was also available for sale via internet
- Lot
- Lot #: 120514, EXP: 12/2014
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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