FDA Recall D-1284-2022
Latin Foods Market · San Jose, CA
Class I — life-threatening Terminated 720 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Arti King Refozado con Ortiga y Omega 3 Tablets, 100-count bottles, Hecho en Mexico por: "PLANTAS MEDICINALES DE MEXICO", Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800 Mexico, UPC 7 501031 111138
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.
Recall record
- Recall number
D-1284-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2022-06-10
- Classified by FDA Center
- 2022-07-21
- FDA published
- 2022-07-20
- Terminated
- 2024-05-30
- Recalling firm
- Latin Foods Market
- Firm location
- San Jose, CA