PlainRecalls
FDA Drug Critical Class I Terminated

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.

Reported: December 25, 2013 Initiated: August 5, 2013 #D-371-2014

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.

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.

Details

Units Affected
9,121 bottles
Distribution
Nationwide, Puerto Rico, and internet sales
Location
New York, NY

Frequently Asked Questions

What product was recalled?
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.. Recalled by Bethel Nutritional Consulting, Inc. Units affected: 9,121 bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 25, 2013. Severity: Critical. Recall number: D-371-2014.