Drug product
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
D-1159-2022
Product summary
- Firm
- Walmart Inc
- Event
- Event 90359
- Status
- Completed
- Classification
- Class II
- Quantity
- 1308 bottles total
- Official record key
drug-enforcement:D-1159-2022
Official wording
Reason: Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Code information: All product lots.
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Unknown
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.