FDA Recall D-1297-2022
Amazon.com, Inc. · Seattle, WA
Class I — life-threatening Terminated 166 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Artri King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES DE MEXICO , Melchor Ocampo No. 55 Local D, Delegacion Xochimilco. C.P. 16800, Mexico, D.F., ASIN B084KSV12L, UPC 7 501031 111190
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Recall record
- Recall number
D-1297-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide within the U.S.A.
- Recall initiated
- 2022-05-26
- Classified by FDA Center
- 2022-07-27
- FDA published
- 2022-07-27
- Terminated
- 2022-11-08
- Recalling firm
- Amazon.com, Inc.
- Firm location
- Seattle, WA