FDA recall D-921-2013

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.

Distribution

Nationwide. Product was also available for sale via internet

Key facts

Status

Terminated

Initiation date

2013-06-11

Report date

2013-09-04

Termination date

2018-06-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-921-2013