FDA (Drugs) recall action 65383
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 found to contain undeclared sibutramine. Sibutramine was removed from the U.S. 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.
Dolphin Intertrade Corporation is recalling JaDera weight loss capsules because they contain undeclared sibutramine, a drug removed from the U.S. market for safety reasons.
Dolphin Intertrade Corporation is recalling XIYOUJI QINGZHI CAPSULES because they contain undeclared sibutramine, a substance removed from the U.S. market for safety reasons.