Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (5...
FDA Recall #D-1296-2022 — Class I — May 26, 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.
Recalling Firm
Amazon.com, Inc. — Seattle, WA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
35,622 cartons
Distribution
Nationwide within the U.S.A.
Code Information
Lot #: 040 19, Exp. 09 FEB 2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated