Why it was recalled
Marketed without 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 U.S
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-0626-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jul 18, 2024
- FDA report date
- Aug 14, 2024
- Quantity
- 57, 340 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MAIN PRODUCTS INC
Original FDA data
Every field from FDA enforcement report D-0626-2024, exactly as published.
Show all FDA fields
- City
- Chula Vista
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 94962
- Address
- 1551 Glenwood Springs Ave
- Code information
- All lots within expiry
- Postal code
- 91913-3910
- Report date
- Aug 14, 2024
- Product type
- Drugs
- Recall number
- D-0626-2024
- Classification
- Class I
- Recalling firm
- MAIN PRODUCTS INC
- Product quantity
- 57, 340 bottles
- Reason for recall
- Marketed without 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 U.S
- Recall initiation date
- Jul 18, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 5, 2024