FDA recall D-1296-2022

Product

Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (500 mg c/u) in a bottle and 60 capsules (400 mg c/u) in a bottle, Hecho en Mexico por: Omega Nutrition , Jorge Washington No. 108 Col. Las Americas, Hidalgo del Parral, Chihuahua. C.P. 33880, ASIN B084L2XM3Z, UPC 3166557819586

Reason for recall

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.

Distribution

Nationwide within the U.S.A.

Key facts

Status

Terminated

Initiation date

2022-05-26

Report date

2022-07-27

Termination date

2022-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Seattle, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1296-2022