Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
Reported: September 4, 2013 Initiated: June 11, 2013 #D-921-2013
Product Description
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.
Details
- Recalling Firm
- Bethel Nutritional Consulting, Inc
- Units Affected
- 18,678 bottles
- Distribution
- Nationwide. Product was also available for sale via internet
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York. Recalled by Bethel Nutritional Consulting, Inc. Units affected: 18,678 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 4, 2013. Severity: Critical. Recall number: D-921-2013.
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