FDAClass ISeptember 4, 2013

Bethel 30 capsules recall

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

Why was Bethel 30 capsules recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 120514, EXP: 12/2014

Product
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
Recalling firm
Bethel Nutritional Consulting, Inc
Quantity
18,678 bottles
Distribution
Nationwide. Product was also available for sale via internet
Recall date
September 4, 2013
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls