FDA (Drugs) recall action 73167
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; FDA analysis found them to contain sibutramine and phenolphthalein
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.
Bee Xtreme is recalling Jenesis Dietary Supplement Capsules because FDA analysis found unapproved ingredients sibutramine and phenolphthalein.
Bee Xtreme LLC is recalling La' Trim Plus dietary supplements because FDA analysis found unapproved drugs sibutramine and phenolphthalein.
Bee Xtreme LLC is recalling Oasis Dietary Supplement Capsules because FDA analysis found the products contain sibutramine and phenolphthalein without an approved NDA or ANDA.