FDA MedWatch - Umary Acido Hialuronico, Suplemento Alimenticio by Main Products

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TOPIC: Umary Acido Hialuronico, Suplemento Alimenticio by Main Products: Recall - Due to the Presence of Undeclared Drug Ingredients: Diclofenac and Omeprazole

AUDIENCE: Consumer, Health Professional, Pharmacy, Pain Management, Gastroenterology

ISSUE: Main Products is recalling all lots of "Umary Acido Hialuronico, Suplemento Alimenticio – 30 Capletas de 850 mg” because 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.

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. PPI medicines may cause serious skin reactions, abdominal pain, diarrhea, nausea, and headache. 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 was distributed via online store Main Products on Amazon.com.

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

BACKGROUND: The product is used as a dietary supplement promoted and sold for pain.

RECOMMENDATIONS: 

• 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 that have Umary which is being recalled should stop using and return to place of purchase. Consumers may return the products to the address below via mail: Main Products, Inc., 1551 Glenwood Springs Ave., Chula Vista CA, 91913.

• Consumers with questions regarding this recall can contact Main Products at mainproductsumaryrecall@gmail.com by e-mail 24 hours a day.

Consumers and health professionals 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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