TOPIC: UNAVY Ácido Hialurónico Caplets and UMOVY Ácido Hialurónico Caplets by UMARY - USA.COM: Recall - Due to the Presence of Undeclared Drug Ingredients Dexamethasone, Diclofenac and Omeprazole
AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy
ISSUE: UMARY USA is recalling all lots of Unavy Ácido Hialurónico (30 caplets/850 mg) and Umovy Ácido Hialurónico (30 caplets/850 mg) because FDA laboratory analysis confirmed that these products are tainted with the drug ingredients Diclofenac, Dexamethasone and Omeprazole. Products containing Diclofenac, Dexamethasone or Omeprazole cannot be marketed as dietary supplements. Unavy Ácido Hialurónico and Umovy Ácido Hialurónico are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries, psychiatric problems, and lead to cardiovascular events. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland (a disorder in which the adrenal glands do not produce enough hormones) and adverse consequences can range from limited adverse consequences to death. Additionally, abrupt discontinuation can cause withdrawal symptoms. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). Consumption of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, in those who have allergies to diclofenac, or those with underlying illnesses. Omeprazole is a proton pump inhibitor (commonly referred to as PPI) used to treat gastric (stomach) acid-related disorders. Consumption of undeclared omeprazole may mask stomach issues such as erosions, ulcers, and stomach cancer. Consumption of undeclared dexamethasone, diclofenac, and omeprazole can also interact with other medications and cause serious side effects.
Umary-usa.com has not received any reports of adverse events related to this recall.
The affected product includes all lots and expiration dates. Product was distributed Nationwide via internet, exclusively via umary-usa.com.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The products being recalled are marketed as dietary supplements for joint pain and arthritis.
RECOMMENDATIONS:
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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.
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Consumers who have any of these products, should immediately work with their physician and/or health care provider to safely discontinue use of these products.
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Consumers with questions regarding this recall can contact umary-usa.com at umaryusa2025@gmail.com, available seven days a week, 24 hours a day.
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