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.
Recall initiated: 20130611
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated