D-1157-2022 Class I
Recall Details
- Product Type
- Drugs
- Report Date
- June 22, 2022
- Initiation Date
- May 24, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1308 bottles total
Product Description
Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800, Mexico, D.F., UPC 7 501031 111190.
Reason for Recall
Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot: LTARTKNGOMG30720, Exp Diciembre 2026