D-1159-2022 Class II
Recall Details
- Product Type
- Drugs
- Report Date
- June 22, 2022
- Initiation Date
- May 24, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1308 bottles total
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
Reason for Recall
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Distribution Pattern
Nationwide in the USA.
Code Information
All product lots.