Drug product
Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement. Manufactured for & Distributed by Nanowellbeing Health, Inc., 14747 Artesia Blvd, #5V, La Mirada, CA 90638. UPC: 7 99475 35350 5.
D-1535-2014
Product summary
- Firm
- Sung Soo Kim
- Event
- Event 68122
- Status
- Terminated
- Classification
- Class I
- Quantity
- 6,336 bottles
- Official record key
drug-enforcement:D-1535-2014
Official wording
Reason: Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.
Code information: Lot #: L1P1-6100 (expiry 6/25/2016) and L1P2-6000 (expiry 9/16/2016).
Distribution pattern: US nationwide and Korea
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.