Drug product
Bella Vi eXtreme ACCELERATOR Dietary Supplement Capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
D-1368-2014
Product summary
- Event
- Event 67810
- Status
- Terminated
- Classification
- Class I
- Quantity
- unknown
- Official record key
drug-enforcement:D-1368-2014
Official wording
Reason: Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Code information: lot # BTRX7654 EXP: 2015/07/08
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein