FDA (Drugs) recall action 67810
The FDA (Drugs) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
The agency’s own wording, quoted from the enforcement report.
Pure Edge Nutrition is recalling Bella Vi BTrim Ultimate Boost capsules because they contain undeclared sibutramine and phenolphthalein.
Pure Edge Nutrition is recalling Bella Vi BTrim MAX dietary supplements because they contain undeclared sibutramine and phenolphthalein and were marketed without FDA approval.
Pure Edge Nutrition is recalling Bella Vi eXtreme ACCELERATOR capsules because they contain undeclared sibutramine and phenolphthalein.
Pure Edge Nutrition is recalling Bella Vi INSANE Bee Pollen capsules because they contain undeclared sibutramine and phenolphthalein.
Pure Edge Nutrition is recalling Bella Vi INSANE AMP'D dietary supplements because they contain undeclared sibutramine and phenolphthalein.
Pure Edge Nutrition is recalling Bella Vi AMP'D UP weight loss capsules because they contain undeclared sibutramine and phenolphthalein.