Recalls / Class I
Class ID-1366-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- lot # BTX13 EXP: 2015/08/15
Why it was recalled
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Recalling firm
- Firm
- Pure Edge Nutrition
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1182 Fischer Blvd Ste 3, N/A, Toms River, New Jersey 08753-3093
Distribution
- Quantity
- unknown
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-10-10
- FDA classified
- 2014-06-12
- Posted by FDA
- 2014-06-18
- Terminated
- 2016-10-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1366-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.