FDA (Drugs) recall action 70444
The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an unapproved drug.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an unapproved drug.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making iNSANE 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.
Detox Transforms is recalling BtRiM Max capsules because they contain undeclared phenolphthalein, making the product an unapproved drug.
Detox Transforms is recalling AMPD GOLD Bee Pollen capsules because they contain undeclared sildenafil, making them unapproved drugs.
The FDA is recalling iNSANE Bee Pollen capsules because they contain undeclared phenolphthalein and fluoxetine, making them unapproved drugs.
Detox Transforms is recalling EDGE Amplified Weight Release capsules because the product contains undeclared phenolphthalein and fluoxetine, making it an unapproved drug.
Detox Transforms is recalling iNDiGO capsules because they contain undeclared phenolphthalein, making the product an unapproved drug.