FDA (Drugs) recall action 67471
The FDA (Drugs) publishes a recall like this one as 10 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 10 pages.
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein.
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine
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.
MyNicNaxs, Inc. is recalling REDUCE WEIGHT FRUTA PLANTA Capsules because they contain undeclared phenolphthalein and were marketed without FDA approval.
MyNicNaxs, Inc. is recalling Slim Xtreme Weight loss capsules because they contain undeclared active pharmaceutical ingredients, including sibutramine, and were marketed without FDA approval.
MyNicNaxs, Inc. is recalling Magic Slim capsules because they contain undeclared active pharmaceutical ingredients and were marketed without an approved NDA or ANDA.
MyNicNaxs, Inc. is recalling Fruta BIO 400 mg capsules because they contain undeclared sibutramine and phenolphthalein.
MyNicKnaxs is recalling weight reduction pills marketed without FDA approval because they contain undeclared phenolphthalein.
MyNicNaxs, Inc. is recalling Meizi Evolution Soft Gel Capsules because the product was marketed without an approved NDA/ANDA and contains undeclared active pharmaceutical ingredients.
MyNicNaxs, Inc. is recalling Jianfeijindan Activity Girl Capsules because they contain an undeclared sibutramine analog and were marketed without FDA approval.
MyNicNaxs, Inc. is recalling Meizitang Strong Version Botanical Slimming capsules because they contain undeclared active pharmaceutical ingredients, including sibutramine.
MyNicNaxs, Inc. is recalling SlimEasy Herbs Capsules because they contain undeclared sibutramine and N-desmethylsibutramine and were marketed without an approved NDA/ANDA.
MyNicNaxs, Inc. is recalling Super Fat Burning Bomb Capsules because they contain undeclared active pharmaceutical ingredients, phenolphthalein and N-desmethylsibutramine.