Why it was recalled
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.
Product description
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
Lot numbers, UPCs & expiration codes
Lot 334 21, Exp: 30 Nov, 2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1284-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 10, 2022
- FDA report date
- Jul 20, 2022
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Latin Foods Market
Original FDA data
Every field from FDA enforcement report D-1284-2022, exactly as published.
Show all FDA fields
- City
- San Jose
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 90427
- Address
- 205 E Alma Ave
- Address (line 2)
- F1
- Code information
- Lot 334 21, Exp: 30 Nov, 2025
- Postal code
- 95112-5902
- Report date
- Jul 20, 2022
- Product type
- Drugs
- Recall number
- D-1284-2022
- Classification
- Class I
- Recalling firm
- Latin Foods Market
- Product quantity
- unknown
- Termination date
- May 30, 2024
- Reason for recall
- Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 10, 2022
- Initial firm notification
- Letter
- Center classification date
- Jul 21, 2022