COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason Description
Tainted with the drug ingredients, diclofenac and omeprazole
- Company Name:
- SoloVital.com
- Brand Name:
- Product Description:
-
Product Description
Umary Acido Hialuronica, Suplemento Alimenticio – 30 Capletas de 850mg
Company Announcement
FOR IMMEDIATE RELEASE – 7/15/2024 – Chula Vista, CA, SoloVital.com is voluntarily recalling all lots of Umary Acido Hialuronica, 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 drug 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.
Risk Statement: 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 at SoloVital.com
SoloVital.com is notifying its customers by email and is arranging for the return of all recalled products. Consumers that have Umary which is being recalled should stop using and return to place of purchase.
Consumers with questions regarding this recall can contact SoloVital.com by e-mail info@solovital.com Mon. – Fri. 9am to 5pm PST, 24 to 48 hours response time. 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.
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.
Company Contact Information
- Consumers:
- SoloVital.com, German Alegre
