The Recall Desk
CriticalFDA (Drugs)·D-1535-2014·Announced 2014-08-20

Super ARTHGOLD Recalled for Undeclared Prescription Drugs

Super ARTHGOLD dietary supplement is being recalled because it contains undeclared prescription drugs and was marketed without FDA approval.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Sung Soo Kim is recalling Super ARTHGOLD 500mg, 120 Capsule Bottle, a dietary supplement manufactured for and distributed by Nanowellbeing Health, Inc. The recall involves 6,336 bottles distributed in the United States and Korea. The affected products include Lot L1P1-6100 (expiry 6/25/2016) and Lot L1P2-6000 (expiry 9/16/2016).

The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product contains undeclared indomethacin, diclofenac, and chlorzoxazone.

Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.

The recalled product

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.
Manufacturer
Sung Soo Kim
Category
Drug — Dietary Supplement
Hazard
Affected units
6,336

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · undeclared drug

See all →