United States
Latin Foods Market is voluntarily recalling one lot, LOTE 334 21, of Artri King Reforzado con Ortiga y Omega 3 tablets to the consumer level. FDA analysis has found the product to be tainted with diclofenac and dexamethasone. The product was distributed Nationwide in the USA, it was sold online at www.latinfoods.com, and in retail stores. To date, Latin Foods Market has not received any reports of adverse events related to this recall.
Diclofenac and dexamethasone are both FDA approved drugs. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) indicated for the management of pain and arthritis and dexamethasone is a corticosteroid indicated for a variety of indications including but not limited to arthritis. The presence of diclofenac and dexamethasone in Artri King Reforzado con Ortiga y Omega 3 renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.
Risk Statement: Consumption of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, in those who have allergies to diclofenac, or those with underlying illnesses. Consumption of undeclared dexamethasone may lead to severe and serious adverse events such as adrenal suppression, a disorder in which the adrenal glands do not produce enough hormones, and adverse consequences can range from limited adverse consequences to death.
Artri King Reforzado con Ortiga y Omega 3 is marketed as a dietary supplement for relief of pain and inflammation associated with arthritis and osteoarthritis and is packaged in 100-count tablets per bottle within a cardboard carton, UPC 7 501031 111138. Latin Foods Market will notify all customers who ordered the product online in writing with an email instructing them to discard all recalled products after reviewing the FDA public notification link below and will post a copy of this press release on the Latin Foods Market website and in the retail stores where it was sold.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Latin Foods Market
Brand name: Arti King
Product recalled: Artri King Reforzado con Ortiga y Omega 3
Reason of the recall: Undeclared Diclofenac and Dexamethasone
FDA Recall date: June 14, 2022
Source:
www.fda.gov
