Drug product
Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
D-1366-2014
Product summary
- Event
- Event 67810
- Status
- Terminated
- Classification
- Class I
- Quantity
- unknown
- Official record key
drug-enforcement:D-1366-2014
Official wording
Reason: Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Code information: lot # BTX13 EXP: 2015/08/15
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein