FDA (Drugs) recall action 77817
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: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved 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.
EZWeightLossTX LLC is recalling LaBri's Body Health XPLODE capsules because they contain sibutramine, an unapproved drug ingredient.
EZWeightLossTX LLC is recalling LaBri's Body Health Atomic 60 Capsules because the product was found to contain sibutramine, an unapproved drug ingredient.