Drug product
iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00404 4.
D-0978-2015
Product summary
- Firm
- Detox Transforms
- Event
- Event 70444
- Status
- Terminated
- Classification
- Class I
- Quantity
- 175 bottles
- Official record key
drug-enforcement:D-0978-2015
Official wording
Reason: Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.
Code information: Lot: 000034, Exp 04/10/17
Distribution pattern: WV who distributed Nationwide.
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.