FDA Warning: Ozempen Not Approved! - MedWaste Management FDA Warning: Ozempen Not Approved! - MedWaste Management

Medical Waste and the Healthcare Industry Blog

Stay tuned to our blog for timely updates and insights into the ever-evolving landscape of medical waste news and developments.

FDA Drug Recall Ozempen

FDA Warning: Ozempen Not Approved!

The FDA has issued a warning letter to the owners of Ozempen.com. The owners are currently offering their product as an alternative to Ozempic, with claims that the Ozempen and Slimaglutide products include the same active ingredient as Ozempic®, Rybelsus®, and Wegovy® at a more affordable price. However, the FDA warning indicates that the drug has not been reviewed or approved by the FDA. Additionally, the drug labels fail to provide “adequate directions for use,” putting users at risk of incorrectly dosing themselves with the drug. The warning orders the company to cease offering the drug immediately.  

At the time of this notice, the pens are still available for sale.

You can view the entire warning letter here.

SUMMARY

Date of Warning:

Announced: June 24, 2024

Public Notification: July 2, 2024

Name(s) of Drug:

Ozempen

Company Name:

Ozempen.com

Drug Indication:

Weight Loss

Product Description

Ozempen.com offers two weight loss injection pens and bottled supplements for sale. Each is packaged individually.

Reason for Warning

The FDA warning indicates that the company is offering these products for sale without FDA approval. While they may appear to be an affordable alternative to the popular weight loss injection, Ozempic, it is unknown whether the product is safe or pure. Injectable weight loss drugs are available by prescription only and require close monitoring by a healthcare professional. The FDA does not approve of the sale of these non-prescription products without approval.

Impacts

Consumers who purchase these products are at risk of severe adverse health effects. Unapproved drugs may contain unsafe substances, may be manufactured under unsanitary conditions, or may be fraudulent. Possible adverse events could include:

  • Injection Site Infection
  • Hypoglycemic Shock (extremely low blood sugar)
  • Coma
  • Seizures
  • Death

Warning Product Information

Consumers should avoid purchasing products from Ozempen.com until they have reconciled their violations with the FDA and come into compliance. If you have purchased this product from Ozempen.com, do not use the product. If you’ve used it, seek medical attention immediately.

Have you found that you are in possession of drugs included in the warning? Here’s what you should do:

Consumers

If you find that you are in possession of drugs included in the warning, you should:

  1. Stop using the medication right away.
  2. Notify your doctor that you have used the medication.
  3. Monitor your health for any adverse symptoms and notify your physician if you have concerns.
  4. 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.
  5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

  1. Examine all inventory and consider removing stock included in the warning.
  2. Notify affected consumers of recalled batches that they have already or will receive.
  3. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and consider removing stock included in the warning.
  2. Notify affected retailers of recalled batches that they have already or will receive.
  3. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

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 

MedWaste’s Blog Index

Medical Waste Regulations

MedWaste’s Product Store 

Learn How To Properly Manage & Dispose of Household Medical Waste

Tammy McKinney, Nurse Writer Healthcare Content Creator Byline Image

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!

I know I can count on you all to collect everything and do it safely.

You are a great company to work with. At our pharmaceutical production laboratory. We have gallons of leftover pharmaceutical waste that are a headache for our techs to deal with. I know I can count on you all to collect everything and do it safely. I’m pleased with the personal service.

M

Mitchell Adam

Got questions? Need our services?

We’ll get back to you by tomorrow — latest!

Fill the form