Warning: This Nasal Spray is NOT FDA Approved - MedWaste Management Warning: This Nasal Spray is NOT FDA 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 warning letter, nasal spray not FDA approved, Covixyl by Salvacion USA

Warning: This Nasal Spray is NOT FDA Approved

The FDA has issued a firm warning to Salvacion USA Inc. after discovering that the company is illegally selling and distributing unapproved drugs to the general public. Salvacion USA Inc. boasts its nasal spray as a safe and effective way to protect the nasal passages from airborne viruses, including Influenza, RSV, Rotovirus, and SARS-CoV-2.

The actual effectiveness of the product is unknown. However, the FDA has determined that the company’s claim to prevent the transmission of illnesses places its product in the “drug” category, and it must be reviewed by the FDA prior to being offered to the general public.

Salvacion USA Inc. has 15 days to develop and implement a corrective action plan. Failure to do so will result in further action, which may include an immediate drug recall. As of the writing of this notice, the company continues to manufacture and distribute the drugs illegally.

SUMMARY

 

Date of Notice:

Announced: February 13, 2024

 

Name(s) of Drug:

Covixyl Nasal Spray

 

Company Name:

Salvacion USA, Inc.

 

Drug Indication:

Prevention of Infection by Airborne Viruses

 

About the Products

The FDA’s warning involves Covixyl Nasal Spray. Salvacion USA, Inc. distributes the nasal spray on their website, www.covixyl.com and through nationwide retailers such as www.target.com and www.amazon.com. Covixyl Nasal Spray is contained in a dark brown spray bottle with a white cap. The label is white with purple, yellow, and orange borders. Each bottle is shipped in a small box bearing the Covixyl logo and its purple, yellow, and orange borders.

Reason for Notice

Salvacion USA, Inc. states that the active ingredient in their Covixyl Nasal Spray is Ethyl Lauroyl Arginate HCL (ELAH), a substance that was granted FDA approval in 2005. However, simply using an FDA approved substance does not indicate that the final product is approved. Salvacion USA, Inc. has been distributing their product without FDA approval and must correct their actions or face penalties by the FDA.

Impacts

Using unapproved drugs places the consumer at risk of life-threatening reactions. Each drug must be approved by the FDA before being sold to the general public. Consumers should always ensure that their medications, even when purchased over the counter, are approved by the FDA.

This notice is urgent and consumers who have purchased substances from Salvacion USA, Inc. should monitor Med Waste Management for upcoming drug recalls related to the investigation.

Consumers

  1. Currently, the FDA has issued no official guidance on recalls or discontinuations of the medications. However, the drugs sold by Salvacion USA, Inc. may be harmful to your health. Notify your physician if you have been utilizing the drugs for further instructions.
  2. If you use any medications from this company, monitor your health for adverse symptoms and notify your physician of any concerns.
  3. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and inform the FDA by calling 1-800-332-1088 or completing an online reporting form.
  4. Dispose of the medication by contacting MedWaste Management for information and assistance.

Retailer

  1. Track drug recalls through the FDA or Med Waste Management websites.
  2. Notify affected consumers when the FDA announces the formal recall.
  3. Contact MedWaste Management for information and assistance with disposing of medications if necessary.

 

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 

MedWaste’s Blog Index

Medical Waste Regulations

MedWaste’s Product Store 

Learn How To Manage & Dispose of Household Medical Waste Properly

 

Tammy McKinney, Nurse Writer Healthcare Content Creator Byline Image

Tammy McKinney, RN, creator 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