In cooperation with the FDA, GURU Inc. has issued a voluntary recall of their Infla-650 Herbal Dietary Supplement capsules. Testing revealed that the capsules contain Acetaminophen, Diclofenac, and Phenylbutazone, drugs not listed on the packaging or approved for inclusion in the supplement. The supplements can cause serious health effects.
As of the writing of this notice, GURU Inc. has not received any reports of adverse events related to this recall.
SUMMARY
Date of Recall:
Announced: July 16, 2024
Public Notification: July 16, 2024
Name(s) of Drug:
Infla-650 Herbal Dietary Supplement Capsules
Company Name:
Guru Inc.
Drug Indication:
Pain
Product Description
Infla-650 Herbal Dietary Supplement is marketed as a pain relief supplement and is sold at www.nutraherbusa.com and www.nutra650.com. The capsules are packaged in 60-count, standup pouches with a green and white label. Each label bears the Infla-650 name and the Guru Inc. logo.
Reason for Recall
Guru Inc. is voluntarily issuing the recall in cooperation with the FDA after testing revealed the presence of undeclared drugs that may be dangerous for consumers. Acetaminophen, Diclofenac, and Phenylbutazone were all found in the supplement. The FDA has not approved the inclusion of the drugs in the supplement, and therefore, its safety cannot be confirmed.
Impacts
Consumers who take the supplement may also unknowingly ingest Acetaminophen, Diclofenac, and Phenylbutazone.
Consumers who inadvertently combine this product with an Acetaminophen containing medication such as Tylenol®, NuQuil®, DayQuil®, Exedrin®, Mucinex®, Robitussin®, Alka-Seltzer Plus®, Goody’s®, and other brands of pain relief and cold/flu products are at high risk of overdose of Acetaminophen. May prescription medications also contain Acetaminophen. Overdose of Acetaminophen can lead to:
- Nausea
- Vomiting
- Sweating
- Skin rashes
- Blisters
- Abdominal pain
- Diarrhea
- Irritability
- Loss of appetite
- Yellowing of the skin and eyes
- Liver failure
- Coma
- Seizures
- Death
Diclofenac and Phenylbutazone are NSAIDs (non-steroidal anti-inflammatory drugs) that can result in severe consequences when taken at high doses. Their 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 these drugs, 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…
Recall Product Information
Consumers who have purchased or ingested products from www.nutraherbusa.com or www.nutra650.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 | Expiration Date |
| Infla-650 | 60 count | IN-032 | Nov 2027 |
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 supplement 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 Guru Inc. with questions at (470)536-9800. They are available Monday through Friday from 9:00 a.m. to 5:00 p.m. EST. They are also available via email at info@nutraherbusa.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 Guru Inc. with questions at (470)536-9800. They are available Monday through Friday from 9:00 a.m. to 5:00 p.m. EST. They are also available via email at info@nutraherbusa.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 Guru Inc. with questions at (470)536-9800. They are available Monday through Friday from 9:00 a.m. to 5:00 p.m. EST. They are also available via email at info@nutraherbusa.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!
