Class I
Terminated
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
- Recall Initiated
- June 11, 2013
- Posted
- September 4, 2013
- Recall Number
- D-921-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 18,678 bottles
- Firm Location
- New York, NY, United States
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
Lot / Code Info
Lot #: 120514, EXP: 12/2014
More recalls by Bethel Nutritional Consulting, Inc
SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.
Jul 15, 2015 · Class I
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