April 2014 FDA Recall Drug by Sung Soo Kim
D-1535-2014 - Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.

This Class I drug recall was voluntarily initiated by Sung Soo Kim on April 15, 2014 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; product contains undeclared indomethacin, diclofenac, and chlorzoxazone.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1535-2014

Reason for Recall
Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.
Initiated
04-15-2014
Reported
08-20-2014
Quantity
6,336 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68122
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sung Soo Kim
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US nationwide and Korea
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : L1P1-6100 (expiry 6/25/2016) and L1P2-6000 (expiry 9/16/2016).