FDA recall D-1157-2022

Product

Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800, Mexico, D.F., UPC 7 501031 111190.

Reason for recall

Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.

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-1157-2022