Drug product
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.
D-371-2014
Product summary
- Event
- Event 65894
- Status
- Terminated
- Classification
- Class I
- Quantity
- 9,121 bottles
- Official record key
drug-enforcement:D-371-2014
Official wording
Reason: 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.
Code information: Lot 10032011, Exp 10/14
Distribution pattern: Nationwide, Puerto Rico, and internet sales
Derived failure modes
-
Unknown
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.