D-0878-2016 Class I Terminated
FDA drug recall D-0878-2016 was initiated by Centro Naturista on June 3, 2015 and is designated Class I. Reason for recall: Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein. The recall status is terminated (terminated March 30, 2017). Affected quantity: Unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- June 1, 2016
- Initiation Date
- June 3, 2015
- Termination Date
- March 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unknown
Product Description
Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Reason for Recall
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
Distribution Pattern
Nationwide
Code Information
All lots