Latin Foods Market has issued a voluntary nationwide recall of Artri King Reforzado Con Ortiga Y Omega 3 capsules. The consumer-level recall is issued because the product contains undeclared diclofenac and dexamethasone.
FDA analysis found that the products contained undeclared diclofenac sodium and dexamethasone. Both Diclofenac and dexamethasone drugs are FDA-approved.
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. Dexamethasone is a steroid hormone used to treat a variety of indications, including inflammation and arthritis. The presence of these drugs in Artri King Reforzado con Ortiga y Omega 3 renders it an unapproved drug for which safety and efficacy have not been established.
Consuming undeclared diclofenac can cause adverse health issues, including gastrointestinal bleeding, cardiovascular issues, and perforation of the stomach and intestines, to patients taking concomitant NSAIDs and/or anticoagulants. Patients with allergies to diclofenac and those with underlying issues are also at risk.
Consuming undeclared dexamethasone may cause suppression of the adrenal gland, where the adrenaline glands fail to produce enough hormones body’s normal response to stress or illness would be impaired. This could lead to adverse consequences and death. Latin Food Market has not received any reports of adverse events to date.
Artri King Reforzado con Ortiga y Omega 3 is a dietary supplement marketed to relieve arthritis and osteoarthritis. The product is packaged in 100-count tablets per bottle in a cardboard carton, UPC 7 501031 111138.
This product was distributed nationwide in the USA through retail stores and was also sold online at www.latinfoods.com.
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Latin Foods Market is notifying its distributors and customers by letter and is arranging for the return of all recalled products. Consumers who have these products are urged to discontinue use and discard them immediately. Consumers and health professionals can refer to FDA’s public notification https://www.fda.gov/drugs/medication-health-fraud/public-notification-artri-king-contains-hidden-drug-ingredients for more information.
Consumers with questions regarding this recall can contact Latin Foods Market Tuesdays and Thursdays from 10:00 a.m. to 12:00 noon Pacific time at 1-800-416-6099 or by email at [email protected].
Consumers who experience any problem which may be related to taking or using this drug product should contact their physician or healthcare provider immediately.
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 the form or call 1- 800-332-1088 to request a reporting form, then complete and return it 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.
Latin Foods Market is a family-owned business that has been serving the Latino community since 2003. We are dedicated to providing our customers with high-quality products and services.
Thank you for your cooperation as we work together to ensure the safety of our products.