FDA (Drugs) recall action 63525
The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.
Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
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.
Zi Xiu Tang Success, LLC is recalling Ultimate Formula capsules because they contain undeclared sibutramine, an ingredient removed from the market for safety reasons.
Zi Xiu Tang Success, LLC is recalling Classic Zi Xiu Tang Bee Pollen Capsules because they contain undeclared sibutramine, an unapproved active ingredient.