Why it was recalled
Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: L1P1-6100 (expiry 6/25/2016) and L1P2-6000 (expiry 9/16/2016).
Where it was sold
US nationwide and Korea
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1535-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 15, 2014
- FDA report date
- Aug 20, 2014
- Quantity
- 6,336 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sung Soo Kim
Original FDA data
Every field from FDA enforcement report D-1535-2014, exactly as published.
Show all FDA fields
- City
- La Mirada
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 68122
- Address
- 14747 Artesia Blvd # 5c
- Code information
- Lot #: L1P1-6100 (expiry 6/25/2016) and L1P2-6000 (expiry 9/16/2016).
- Postal code
- 90638-6008
- Report date
- Aug 20, 2014
- Product type
- Drugs
- Recall number
- D-1535-2014
- Classification
- Class I
- Recalling firm
- Sung Soo Kim
- Product quantity
- 6,336 bottles
- Termination date
- Sep 22, 2014
- Reason for recall
- Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- US nationwide and Korea
- Recall initiation date
- Apr 15, 2014
- Initial firm notification
- Letter
- Center classification date
- Aug 8, 2014