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

FDA recall notice · announced September 4, 2013 · Bethel Nutritional Consulting

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Nationwide. Product was also available for sale via internet
Lot/code information: Lot #: 120514, EXP: 12/2014
Quantity: 18,678 bottles
Status: Terminated
Products in this recall event:
- Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York (D-921-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.