Drug 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
D-1297-2022
Product summary
- Firm
- Amazon.com, Inc.
- Event
- Event 90627
- Status
- Terminated
- Classification
- Class I
- Quantity
- 15,087 bottles
- Official record key
drug-enforcement:D-1297-2022
Official wording
Reason: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Code information: Lot #: LTARTKNGOMG30720, Exp. Diciembre 2026 (December 2026)
Distribution pattern: Nationwide within the U.S.A.
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.