FDA Recall D-1366-2014
Pure Edge Nutrition · Toms River, NJ
Class I — life-threatening Terminated 1093 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Reason for recall
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Recall record
- Recall number
D-1366-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide
- Recall initiated
- 2013-10-10
- Classified by FDA Center
- 2014-06-12
- FDA published
- 2014-06-18
- Terminated
- 2016-10-07
- Recalling firm
- Pure Edge Nutrition
- Firm location
- Toms River, NJ