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

Recall Number D-921-2013

Classification Class I

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

Product Distributed Qty 18,678 bottles

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.

Event Detail

Event Id 65441

Product Type Drugs

Status Ongoing

Recalling Firm

Bethel Nutritional Consulting, Inc
City New York
State NY

Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-06-11

Initial Firm Notification of Consignee or Public Two or more of the following: Email,
Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern Nationwide. Product was also available for sale via internet