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Recall Observatory FDA recall evidence

Drug product

Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York

D-921-2013

June 11, 2013

Class I

Product summary

Firm
Bethel Nutritional Consulting, Inc
Event
Event 65441
Status
Terminated
Classification
Class I
Quantity
18,678 bottles
Official record key
drug-enforcement:D-921-2013

Official wording

Reason: 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.

Code information: Lot #: 120514, EXP: 12/2014

Distribution pattern: Nationwide. Product was also available for sale via internet

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.