FDA recall D-1159-2022

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

Reason for recall

Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.

Distribution

Nationwide in the USA.

Key facts

Status

Completed

Initiation date

2022-05-24

Report date

2022-06-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bentonville, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1159-2022