FDA (Drugs) recall action 74588
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: Undeclared sibutramine.
The agency’s own wording, quoted from the enforcement report.
Dream Body Weight Loss is recalling Dream Body Extreme Gold capsules because they contain undeclared sibutramine and were marketed without FDA approval.
Dream Body Weight Loss is recalling Dream Body 450 mg capsules because they contain undeclared sibutramine and were marketed without FDA approval.
Dream Body Advanced 400 mg capsules are being recalled because they contain undeclared sibutramine and were marketed without an approved NDA/ANDA.