FDA Alert: Dietary Supplement Marketed for Pain Relief Recalled Due to Presence of Diclofenac and Dexamethasone

Company Announcement

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

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. The product was distributed Nationwide in the USA, it was sold online at www.latinfoods dot com, and in retail stores.

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. 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 with questions regarding this recall can contact Latin Foods Market by phone at 1-800-416-6099 or e-mail Support@LatinFoodsMarket.com on Tuesdays and Thursdays from 10:00 a.m. to 12:00 noon Pacific time. 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.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.