FDA-Drug2013-09-04Class I
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
Bethel Nutritional Consulting, Inc
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.
Sold states
Nationwide. Product was also available for sale via internet
Affected count
18,678 bottles
Manufactured in
599 W 190th St Ste 1, New York, NY, United States
Products
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-921-2013Don't want to check this manually?
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