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Class I: serious health riskOngoing

SoloVital Umary Acido Hialuronico Recall

Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count b…

SoloVital · Chula Vista, CA

Risk level
Class I
Reported by FDA
Aug 7, 2024
Recall ID
D-0620-2024
Check your lot numberHow we source this data

Summary

SoloVital recalled Umary Acido Hialuronico starting Jul 12, 2024. The FDA classified it as Class I (serious health risk) and published enforcement report D-0620-2024 on Aug 7, 2024. Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole. Status: Ongoing.

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
E-Mail
Center classification date
Jul 29, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0620-2024, published Aug 7, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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