Products found to contain undeclared medicines
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| The United States: Main Products, Inc. issues voluntary nationwide recall of Umary Acido Hialuronico, Suplemento Alimenticio due to the presence of undeclared drug ingredients: diclofenac and omeprazole |
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The United States Food and Drug Administration (FDA) announces that Chula Vista, CA – Main Products, Inc. is voluntarily recalling all lots of Umary Acido Hialuronico, Suplemento Alimenticio – 30 Capletas de 850mg 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.
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 is used as a dietary supplement promoted and sold for pain and is packaged in bottles with 30 caplets. The affected product includes all lots within expiry. The product was distributed via online store Main Products, Inc. on Amazon.com.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/main-products-inc-issues-voluntary-nationwide-recall-umary-acido-hialuronico-suplemento-alimenticio
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 16 Jul 2024.
Ends/Tuesday, Jul 23, 2024
Issued at HKT 16:00
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