FDA MedWatch - Artri King Reforzado Con Ortiga Y Omega 3 by Latin Foods Market:

U.S. Food and Drug Administration sent this bulletin at 06/15/2022 09:54 AM EDT

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: Artri King Reforzado Con Ortiga Y Omega 3 by Latin Foods Market: Recall - Due to the Presence of Undeclared Diclofenac and Dexamethasone

AUDIENCE: Consumer, Health Professional, Pharmacy

ISSUE: Latin Foods Market is recalling one lot, LOTE 334 21, of Artri King Reforzado con Ortiga y Omega 3 tablets because FDA analysis has found the product to be tainted with diclofenac and dexamethasone. 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.

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.

To date, Latin Foods Market has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: 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.

RECOMMENDATIONS:

Consumers that have this product should refer to FDAs public notification https://www.fda.gov/drugs/medication-health-fraud/public-notification-artri-king-contains-hidden-drug-ingredients and work with their health care professional to safely discontinue use of this product.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Consumers with questions regarding this recall can contact the company.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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