The FDA has issued a recall of Umary Acido Hialuronica, Suplemento Alimenticio, a dietary supplement distributed by SoloVital.com. The supplement is tainted with both diclofenac and omeprazole. The inclusion of these drugs in the supplement must be FDA-approved prior to distribution, and the company has not taken appropriate steps to obtain approval. Therefore, the supplement’s safety cannot be confirmed.
As of the writing of this notice, the FDA has not announced any reports of adverse events related to this recall.
SUMMARY
Date of Recall:
Announced: July 15, 2024
Public Notification: July 15, 2024
Name(s) of Drug:
UMARY
Umary Acido Hialuronica, Suplemento Alimenticio, 850mg
Company Name:
SoloVital.com
Drug Indication:
Pain
Product Description
Umary Acido Hialuronica, Suplemento Alimenticio is sold directly to consumers at www.SoloVital.com. The product is packaged in black and blue bottles with white caps, each containing 30 caplets, each 850 mg. The label bears the name UMARY with the subtext Acido Hialuronico, Suplemento Alimenticio.
Reason for Recall
The FDA performed a laboratory analysis that discovered the presence of diclofenac and omeprazole. These ingredients are drugs that must be approved for use and distribution. The company has not met the guidelines for distributing these drugs, and therefore, its product is under recall.
Impacts
Consumers who take the supplement may also unknowingly ingest both diclofenac and omeprazole.
Diclofenac is an NSAID (non-steroidal anti-inflammatory drug) that can result in severe consequences when taken at high doses. Its use can lead to an increased risk of heart attack, bleeding in the stomach or intestines, Hyperkalemia (high blood potassium), delayed ovulation in women, and Stevens-Johnson syndrome (a severe skin reaction). While taking this drug, you may experience side effects such as:
- Stomach upset
- Belching
- Bleeding gums
- Bloody urine
- Bloody stools
- Chest pain
- Chills
- Constipation
- Decreased urine output
- Dizziness
- Yellow eyes and skin
- Difficulty sleeping
- Irritability
- Confusion
- Depression
- And more…
Omeprazole is a PPI (proton pump inhibitor) used to treat stomach disorders. Taking this medication can mask the symptoms of serious stomach issues such as ulcers and stomach cancer. It may also alter the effectiveness of other medications you are taking. It can cause serious reactions such as:
- Abdominal pain
- Diarrhea
- Nausea
- Headache
- Infection or fever in children
- Decreased kidney function
- Severe skin reactions
- Vitamin B-12 deficiency
- Hypomagnesemia
- Bone loss and fractures
- Lupus
Recall Product Information
Consumers who believe they may have purchased or ingested products from SoloVital.com should check their supplements to confirm if they are included in the recall. Those who have used or currently possess the supplements listed must read further for instructions on participating in the FDA recall.
| Product Description | Count | Lot Number |
| UMARY, 850mg | 30 count | All lots within expiry |
www.fda.gov
Have you found that you are in possession of drugs included in the recall? Here’s what you should do:
Consumers
If you find that you are in possession of drugs included in the recall, you should:
- Stop using the medication right away.
- Notify your doctor that you have used the medication.
- Monitor your health for any adverse symptoms and seek medical attention if you have concerns.
- If you are experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact SoloVital.com with questions at info@solovital.com.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock included in the recall.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact SoloVital.com with questions at info@solovital.com.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and consider removing stock included in the warning.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact SoloVital.com with questions at info@solovital.com.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
We are MedWaste Management – California’s medical waste disposal experts!
Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal in the healthcare industry and the general public. We publish this blog to spread useful and practical information to help you stay safe, smart, and healthy!
Call us with any questions or to start service at (866) 254-5105. We are always happy to help!
Check out our services and other great resources in the links below.
Medical Waste Disposal Services
Learn How To Properly Manage & Dispose of Household Medical Waste
Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!
