PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: July 27, 2022 Initiated: May 26, 2022 #D-1296-2022

Product Description

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.

Details

Recalling Firm
Amazon.com, Inc.
Units Affected
35,622 cartons
Distribution
Nationwide within the U.S.A.
Location
Seattle, WA

Frequently Asked Questions

What product was recalled?
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. Recalled by Amazon.com, Inc.. Units affected: 35,622 cartons.
Why was this product recalled?
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 27, 2022. Severity: Critical. Recall number: D-1296-2022.