Why it was recalled
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Product description
Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottles labeled with UPC 7 501031 111190 and UPC 6 09002 40885, and b) 2 pack of 100-count bottles per carton UPC 3 72426 01434
Lot numbers, UPCs & expiration codes
All product lots.
Where it was sold
Nationwide in the USA.
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-1159-2022
- Classification
- Class II
- Status
- Completed
- Recall initiated
- May 24, 2022
- FDA report date
- Jun 22, 2022
- Quantity
- 1308 bottles total
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Walmart Inc
Original FDA data
Every field from FDA enforcement report D-1159-2022, exactly as published.
Show all FDA fields
- City
- Bentonville
- State
- AR
- Status
- Completed
- Country
- United States
- Event ID
- 90359
- Address
- 702 Sw 8th St Ms 275
- Code information
- All product lots.
- Postal code
- 72716-6299
- Report date
- Jun 22, 2022
- Product type
- Drugs
- Recall number
- D-1159-2022
- Classification
- Class II
- Recalling firm
- Walmart Inc
- Product quantity
- 1308 bottles total
- Reason for recall
- Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottles labeled with UPC 7 501031 111190 and UPC 6 09002 40885, and b) 2 pack of 100-count bottles per carton UPC 3 72426 01434
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- May 24, 2022
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jun 24, 2022