Why it was recalled
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Product description
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
Lot numbers, UPCs & expiration codes
All lots within Expiry
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0620-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jul 12, 2024
- FDA report date
- Aug 7, 2024
- Quantity
- 1,331 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SoloVital
Original FDA data
Every field from FDA enforcement report D-0620-2024, exactly as published.
Show all FDA fields
- City
- Chula Vista
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 94978
- Address
- 2571 Mast Way
- Address (line 2)
- #203
- Code information
- All lots within Expiry
- Postal code
- 91914-4539
- Report date
- Aug 7, 2024
- Product type
- Drugs
- Recall number
- D-0620-2024
- Classification
- Class I
- Recalling firm
- SoloVital
- Product quantity
- 1,331 bottles
- Reason for recall
- Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 12, 2024
- Initial firm notification
- Center classification date
- Jul 29, 2024