Drug 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
D-1296-2022
Product summary
- Firm
- Amazon.com, Inc.
- Event
- Event 90627
- Status
- Terminated
- Classification
- Class I
- Quantity
- 35,622 cartons
- Official record key
drug-enforcement:D-1296-2022
Official wording
Reason: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Code information: Lot #: 040 19, Exp. 09 FEB 2025
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.