FDA recall D-1535-2014

Sung Soo Kim · Class I · 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.

Reason for recall

Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.

Distribution

US nationwide and Korea

Key facts

Status
Terminated
Initiation date
2014-04-15
Report date
2014-08-20
Termination date
2014-09-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
La Mirada, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1535-2014