D-0978-2015 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 13, 2015
- Initiation Date
- January 25, 2015
- Termination Date
- January 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 175 bottles
Product Description
iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00404 4.
Reason for Recall
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.
Distribution Pattern
WV who distributed Nationwide.
Code Information
Lot: 000034, Exp 04/10/17