UNAVY ACIDO HIALURONICO supplement recalled for undeclared pharmaceutical ingredients
UNAVY ACIDO HIALURONICO hyaluronic acid supplement is being recalled because it contains three undeclared pharmaceutical ingredients: Dexamethasone, Diclofenac, and Omeprazole. The product was marketed without FDA approval and poses health risks from the unlisted drugs.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall of a drug product marketed without approval containing undeclared pharmaceutical ingredients that pose serious health risks through potential drug interactions and adverse effects, meeting the Class I threshold for severe classification.
Plain-English summary
UNAVY ACIDO HIALURONICO, a hyaluronic acid supplement sold in 30-count bottles of 850mg capsules, is being recalled. The product is distributed by EREN NATURAL S.A. DE C.V and sold by Umary-USA.com under UPC 7 503046 054295. Laboratory analysis found the product contains three undeclared pharmaceutical ingredients: Dexamethasone (a corticosteroid), Diclofenac (a nonsteroidal anti-inflammatory drug), and Omeprazole (a proton pump inhibitor). The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) from the FDA.
The presence of these undeclared pharmaceutical ingredients creates a serious health risk. Consumers taking this product may unknowingly ingest powerful medications that can interact with other drugs, cause adverse effects, or worsen existing medical conditions. All lots and expiration dates are affected. Approximately 1,342 bottles of the 30-count product have been distributed nationwide via the internet.
Consumers who have purchased this product should stop use immediately and consult with a healthcare provider, particularly if they have taken multiple doses. Those with questions or concerns should contact their physician or pharmacist. The product should not be used or transferred to others.
The recalled product
- Product
- UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295
- Manufacturer
- Umary-USA.com
- Hazard
- undeclared-pharmaceutical-ingredients
- unapproved-drug-product
- dexamethasone
- diclofenac
- omeprazole
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All Lots
- All Expiration Dates.
Distribution
Distributed nationwide across the United States.
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