FDA (Drugs) recall action 71187
The FDA (Drugs) publishes a recall like this one as 14 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 14 pages.
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared fluoxetine, an FDA approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.
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 Extremely Amazed LLC is recalling XCEL Capsules marketed as a dietary supplement because they contain undeclared fluoxetine and phenolphthalein.
Bee Extremely Amazed LLC is recalling Prime Capsules because they contain undeclared sibutramine and phenolphthalein, making them unapproved drugs.
Bee Extremely Amazed LLC is recalling Oasis Capsules because they contain undeclared sibutramine and phenolphthalein, making them unapproved drugs.
Bee Extremely Amazed LLC is recalling ZI XIU TANG Beauty Face & Figure Capsules because they contain undeclared sibutramine, a withdrawn drug.
Bee Extremely Amazed LLC is recalling La' Trim Plus Capsules because the product contains undeclared sibutramine and phenolphthalein, both withdrawn from the US market for safety reasons.
Bee Extremely Amazed LLC is recalling Infinity Capsules because the product was found to contain undeclared sibutramine, a withdrawn appetite suppressant.
Bee Extremely Amazed LLC is recalling Ultimate Formula Capsules because they contain undeclared sibutramine, a withdrawn drug.
Bee Extremely Amazed LLC is recalling SLIM TRIM U Capsules because they contain undeclared sibutramine, a withdrawn drug.
Bee Extremely Amazed LLC is recalling Asset BOLD Capsules because they contain undeclared sibutramine and phenolphthalein, making them unapproved drugs.
Bee Extremely Amazed LLC is recalling Jenesis Capsules marketed as a dietary supplement because they contain undeclared sibutramine and phenolphthalein, both withdrawn from the US market for safety reasons.
Bee Extremely Amazed LLC is recalling XCEL Advanced Capsules because they contain undeclared phenolphthalein, a withdrawn ingredient with carcinogenic concerns.
Bee Extremely Amazed LLC is recalling Asset extreme+PLUS Capsules because the product was found to contain undeclared sibutramine, a withdrawn appetite suppressant.
Bee Extremely Amazed LLC is recalling EVOLVE BEE POLLEN Capsules nationwide because they contain undeclared sibutramine and phenolphthalein, both withdrawn from the US market for safety reasons.
The FDA is recalling SlimeX-15 Capsules because they contain undeclared sibutramine, a withdrawn drug. Consumers should stop using the product.