FDA Recall D-1157-2022
Walmart Inc · Bentonville, AR
Class I — life-threatening Completed 1451 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-1157-2022- Classification
- Class I
- Status
- Completed
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide in the USA.
- Recall initiated
- 2022-05-24
- Classified by FDA Center
- 2022-06-24
- FDA published
- 2022-06-22
- Recalling firm
- Walmart Inc
- Firm location
- Bentonville, AR