US Drug Recall Register
Class I · High risk Terminated Initiated Jan 25, 2015 (12 years ago)

iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W…

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.

What was recalled

iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00404 4.

Recalling firm
Detox Transforms
Origin
NC, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0978-2015

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.