Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:

Recall Reason Description

The product contains undeclared diclofenac and omeprazole

Company Name:
MXBBB
Brand Name:
Product Description:

Product Description

UMARY Hyaluronic Acid tablets

Company Announcement

MXBBB is voluntarily recalling 1 lot of UMARY ACID HYALURONIC, 30 CAPLETS 850 MG to the consumer level. The products have been found to have omeprazole and diclofenac. FDA laboratory analysis 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. MXBBB has not received any reports of adverse events related to this recall till date.

UMARY was distributed Nationwide Via Amazon.

The product is used as dietary supplement and is packaged in a plastic container. The affected UMARY Acid hyaluronic. UPC:7502265120323 lots include the following Lot number: 24183 and the expiration date: 07/01/24. The product can be identified by providing additional details about how product can be identified by users. 321 units were distributed.

MXBBB is notifying its distributors and customers by Amazon and is arranging for the return of all recalled products. Consumers/distributors/retailers that have Umary which is being recalled should stop using/return to place of purchase for a full refund. 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 with questions regarding this recall can contact MXBBB by (915)259-6936 or Joshua980810@outlook.com 24/7.

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.

FDA Advisory page