FDA Recall D-1535-2014
Sung Soo Kim · La Mirada, CA
Class I — life-threatening Terminated 160 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Reason for recall
Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.
Recall record
- Recall number
D-1535-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- US nationwide and Korea
- Recall initiated
- 2014-04-15
- Classified by FDA Center
- 2014-08-08
- FDA published
- 2014-08-20
- Terminated
- 2014-09-22
- Recalling firm
- Sung Soo Kim
- Firm location
- La Mirada, CA