FDA MedWatch - Umary Acid Hyaluronic by Mxbbb: Recall

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TOPIC: Umary Acid Hyaluronic by Mxbbb: Recall - Due to the Presence of Diclofenac and Omeprazole

AUDIENCE: Consumer, Health Care Professional

ISSUE: MXBBB is recalling one lot, 24183, of Umary Acid Hyaluronic because the product has been found to have omeprazole and diclofenac. FDA did a laboratory analysis that confirmed that Umary contains diclofenac and omeprazole.

Risk Statement: The product diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.

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 headaches. This hidden ingredient may mask stomach issues such as erosion, ulcers, and stomach cancer, and it can also interact with other medications and should not be taken with certain medications. 

Umary was distributed nationwide via Amazon.

MXBBB 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: Umary is used as dietary supplement. The product diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as an NSAID). Omeprazole is a proton pump inhibitor (commonly referred to as PPI) used to treat gastric (stomach) acid-related disorders.

RECOMMENDATIONS: 

• Consumers should contact their physician or health care 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/return to place of purchase for a full refund.
• Consumers with questions regarding this recall can contact MXBBB by email.
• MXBBB is notifying its customers by Amazon and is arranging for the return of all recalled products. 

Health care professionals and consumers 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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