Safety Report: Umary Acido Hialuronico, Suplemento Alimenticio - recalled due to Undeclared Drug Ingredients, USA

United States

Main Products, Inc. is voluntarily recalling all lots of “Umary Acido Hialuronico, Suplemento Alimenticio to the consumer level. FDA laboratory analysis confirmed that UMARY has been found to be tainted with the drug ingredients, diclofenac and omeprazole. Products containing diclofenac and omeprazole cannot be marketed as dietary supplements. Umary is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall. The product was distributed via the online store Main Products, Inc. on Amazon.com.

Risk Statement: Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). There is a reasonable probability that consumption of high levels of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, such as Warfarin, in those who have allergies to diclofenac, or those with underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses.

Omeprazole is a proton pump inhibitor (commonly referred to as PPI) used to treat gastric (stomach) acid-related disorders.This hidden ingredient may mask stomach issues such as erosions, ulcers, and stomach cancer, and it can also interact with other medications and should not be taken with certain medications.

The product is used as a dietary supplement promoted and sold for pain and is packaged in bottles with 30 caplets - 850mg. The affected product includes all lots within expiry.

Consumers that have Umary which is being recalled should stop using it and return to the place of purchase. 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.

In case you experience 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. If symptoms persist, seek medical care.

Company name: Main Products, Inc.
Brand name: Umary
Product recalled: Umary Acido Hialuronico, Suplemento Alimenticio
Reason of the recall: Undeclared Drug Ingredients: Diclofenac and Omeprazole
FDA Recall date: July 22, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/main-products-inc-issues-voluntary-nationwide-recall-umary-acido-hialuronico-suplemento-alimenticio