D-371-2014 Class I Terminated
FDA drug recall D-371-2014 was initiated by Bethel Nutritional Consulting, Inc on August 5, 2013 and is designated Class I. 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 pro… The recall status is terminated (terminated May 30, 2018). Affected quantity: 9,121 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 25, 2013
- Initiation Date
- August 5, 2013
- Termination Date
- May 30, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,121 bottles
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.
Distribution Pattern
Nationwide, Puerto Rico, and internet sales
Code Information
Lot 10032011, Exp 10/14