Products found to contain undeclared medicines
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| The United States: Mxbbb issues voluntary nationwide recall of Umary Acid Hyaluronic due to the presence of diclofenac and omeprazole |
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The United States Food and Drug Administration (FDA) announces that MXBBB is voluntarily recalling one lot of Umary Acid Hyaluronic, 30 caplets 850 mg (lot number: 24183) to the consumer level. The products have been found to have omeprazole and diclofenac. FDA laboratory analysis confirmed that Umary contains diclofenac and omeprazole.
The product diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs) used for the relief of pain and inflammation in various conditions. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mxbbb-issues-voluntary-nationwide-recall-umary-acid-hyaluronic-due-presence-diclofenac-and
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by Health Canada and FDA, and was posted on the Drug Office website since 16 May 2024, with the latest update posted on 30 Sep 2024.
Ends/Thursday, Nov 21, 2024
Issued at HKT 14:45
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