FDA (Drugs) recall action 66469
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
B @ B Trade Inc. is recalling Slim Fortune capsules because they contain undeclared sibutramine and were marketed without FDA approval.
B @ B Trade Inc. is recalling Slim Expert softgels because they contain undeclared sibutramine and were marketed without FDA approval.
B @ B Trade Inc. is recalling Lidiy capsules because the dietary supplement was marketed without FDA approval and contains undeclared sibutramine.