D-1369-2014 Class I Terminated
FDA drug recall D-1369-2014 was initiated by Pure Edge Nutrition on October 10, 2013 and is designated Class I. Reason for recall: Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein The recall status is terminated (terminated October 7, 2016). Affected quantity: unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- June 18, 2014
- Initiation Date
- October 10, 2013
- Termination Date
- October 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
Bella Vi INSANE AMP'D 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
Distribution Pattern
Nationwide
Code Information
lot # VINA2013 EXP: 2015/06/12