Chula Vista, California-based SoloVital.com has recalled all lots of its 30-caplet bottles of Umary Acido Hialuronica, Suplemento Alimenticio because the product has been found to contain two undeclared drug ingredients: diclofenac and omeprazole.
The company announced the voluntary, consumer-level recall on July 15, 2024, after a laboratory analysis conducted by the FDA revealed the contamination. Officials note that because of the presence of the two ingredients, Umary cannot be marketed and sold as a dietary supplement. In addition, due to its unapproved status, the safety and efficacy of Umary has not been confirmed.
Promoted and sold for pain management, affected Umary bottles “within expiry” were distributed via SoloVital.com’s online store.
As a non-steroidal anti-inflammatory drug (typically known as NSAIDs), officials have identified a “reasonable probability” that consuming high levels of undeclared diclofenac may lead to major adverse events like “cardiovascular, gastrointestinal, renal, and anaphylaxis” in the following groups:
- patients on a regimen of concomitant NSAIDs and/or anticoagulants (like Warfarin)
- patients with a diclofenac allergy
- patients with “underlying cardiovascular, gastrointestinal, renal, and hepatic illness.”
As a proton pump inhibitor (PPI) indicated for treatment of gastric (stomach) acid-related disorders, omeprazole (and other PPI medicines) has been known to
- produce the following symptoms: “skin reactions, abdominal pain, diarrhea, nausea, and headache.”
- cause stomach issues like “erosions, ulcers, and stomach cancer”
- cause adverse interactions with other medications (and so should not be taken with specific medications)
SoloVital.com customers affected by the recall should expect to receive an email alert with information about a return program being established by the company. Anyone who may have recalled bottles of Umary is urged to discontinue use and return the item to the point of purchase.
Those with other recall-related questions are encouraged to reach out to SoloVital.com via email at info@solovital.com on Monday through Friday, from 9:00 a.m. to 5:00 p.m. Pacific Time. Consumers can expect to receive a response within 24 to 48 hours. Those who are experiencing health problems believed to be related to use of the drug product should consult their healthcare provider.
As the FDA continues to oversee this recall, any such adverse reactions or issues connected to the recall should also be reported to the agency’s MedWatch Adverse Event Reporting program using the methods listed in the announcement.
If you or a family member has suffered an adverse health outcome that can be traced to an undeclared drug ingredient, we would like to help you fight for the compensation you deserve. Our trusted attorneys at TruLaw work tirelessly to defend consumer safety standards and hold negligent parties responsible. Contact us today or take our free Instant Case Evaluation ℠ to get started.