Dietary supplement tainted with undeclared pharmaceuticals recalled nationwide
Umary Acido Hialuronico dietary supplement (850 mg caplets) was recalled nationwide by the FDA for containing undeclared Diclofenac and Omeprazole. The product was marketed without an approved drug application.
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 product marketed without approved drug application and tainted with undeclared pharmaceuticals. Per the severity rubric, FDA Class I recalls must score 4 or higher; the source reports no deaths or serious injuries, preventing a higher score.
Plain-English summary
Umary Acido Hialuronico, a dietary supplement in 850 mg caplet form, is being recalled nationwide. The product is packaged in 30-count bottles and was manufactured by MAIN PRODUCTS INC. Approximately 57,340 bottles were distributed to U.S. consumers.
The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The FDA's analysis determined that the product contains two undeclared pharmaceutical ingredients: Diclofenac and Omeprazole. These substances were not disclosed to consumers.
The FDA classifies this as a Class I recall. All lots of the product within their expiration dates are affected. Consumers who have purchased this product should stop using it and discard it or return it to the retailer.
The recalled product
- Product
- Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
- Manufacturer
- MAIN PRODUCTS INC
- Category
- Drug — Dietary Supplement
- Hazard
- undeclared-medication
- 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 (1)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
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