UMOVY ACIDO HIALURONICO supplement recalled for undeclared prescription drugs
UMOVY ACIDO HIALURONICO dietary supplement has been recalled because it contains undeclared prescription ingredients Dexamethasone and Diclofenac. The product was marketed without FDA approval.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall for a drug product containing undeclared prescription medications. Undeclared Dexamethasone and Diclofenac pose serious health risks including drug interactions and adverse effects, meeting the Severe criterion even without reported hospitalizations in the source text.
Plain-English summary
UMOVY ACIDO HIALURONICO, a 30-capsule supplement bottle (850mg) distributed by EREN NATURAL S.A. DE C.V and sold by Umary-USA.com, has been recalled nationwide. Laboratory analysis found the product to be tainted with two undeclared prescription ingredients: Dexamethasone (a corticosteroid) and Diclofenac (a nonsteroidal anti-inflammatory drug).
The product was marketed and distributed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) from the FDA. All lots and all expiration dates are included in this recall.
Consumers who have purchased this product should stop using it immediately. The presence of undeclared prescription drugs poses serious health risks, including potentially dangerous drug interactions, adverse effects, and overdose. Anyone who has consumed this product and is experiencing symptoms should contact their healthcare provider or poison control.
The recalled product
- Product
- UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134
- Manufacturer
- Umary-USA.com
- Category
- Drug — Dietary Supplement
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.
Part of a larger recall action
This product is one of 2 recalled by Umary-USA.com under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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