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Supplements Recalled for Containing Drug Ingredients
SoloVital.com, based in Chula Vista, California, is recalling all lots of the dietary supplement Umary Acido Hialuronico, Suplemento Alimenticio.
According to a company announcement dated July 15, 2024, the recall was prompted by a US Food and Drug Administration (FDA) analysis that confirmed the supplements were tainted with diclofenac and omeprazole. Diclofenac is a nonsteroidal anti-inflammatory drug, and omeprazole is a proton pump inhibitor.
“Products containing diclofenac and omeprazole drug cannot be marketed as dietary supplements,” SoloVital.com stated in the announcement. “Umary is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.”
The FDA designated the recall Class I, its most serious recall classification. The designation communicates use of the affected product could cause serious adverse health consequences or death.
According to the August 7, 2024, FDA Enforcement Report, the recall affects a total 1331 bottles of Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets. The product was packaged in 30-count bottles and distributed throughout the United States.
SoloVital.com voluntarily initiated the recall on July 12, 2024. On July 29, 2024, the FDA issued its Class I designation.
Umary Acido Hialuronica is a dietary supplement promoted and sold for pain.