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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powder, alfalfa, mulberry leaf, guarana, spirulina) capsules, 400 mg, 30-count bottle, Distributed by: Bethel, Inc., Tel: (212) 568-5330.
Recall Number D-371-2014
Classification Class I
Code Info Lot 10032011, Exp 10/14
Product Distributed Qty 9,121 bottles
Reason For Recall Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and phenolphthalein. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.

Event Detail

Event Id 65894
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 2013-08-05
Initial Firm Notification of Consignee or Public Press Release
Distribution Pattern Nationwide, Puerto Rico, and internet sales