Nationwide Recall of Sinus Spray - MedWaste Management Nationwide Recall of Sinus Spray - 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.

ION* Intelligence of Nature Sinus Spray and Support Recall

Nationwide Recall of Sinus Spray

The FDA has issued an immediate recall of all lots of ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray due to the presence of potentially deadly bacteria. The manufacturer, Biomic Sciences, is working in cooperation with the FDA to recall lots distributed between June 2017 and September 2023. As of the writing of this notice, no adverse effects have yet been reported.

SUMMARY

Date of Recall:

Announced: September 29, 2023

Public Notification: October 2, 2023

Name(s) of Drug:

ION* Sinus Support Nasal Spray

ION* Biome Sinus Nasal Spray

Restore Sinus Spray

Company Name:

Biomic Sciences

Drug Indication:

Nasal Rinse

Post-Operative Nasal Rinse

ION* Sinus Support Recall ION* Biome Sinus Recall Restore Sinus Spray Recall

Product Description

Each spray is individually bottled and packaged in a box labeled with brand information. The nasal spray dispensers are clearly marked with the brand or spray name. Wholesale and retail locations nationwide and online distributed the over-the-counter nasal sprays. The products were also sold directly to consumers at IntelligenceofNature.com.

Reason for Recall

During routine testing, the FDA noted that several pathogenic and nonpathogenic bacteria were present in the nasal spray. While some of the microorganisms identified are unlikely to become pathogenic, others are prone to causing deadly infections.

Impacts

Consumers, particularly those with a recent sinus or nasal surgery history, who continue to use the contaminated nasal spray are at risk of contracting deadly infections. The bacteria found within the spray can lead to serious complications within the nasal passage. These infections can spread quickly throughout the body, possibly leading to death.

Recall Lot Information

All lots of the sprays listed that were sold during the identified sales period are being recalled. Consumers who possess sprays that may have been distributed during the times listed should read further to determine what actions must be taken to participate in the recall.

Product Description
Sales Period
ION* Sinus Support

Sept 2021-Sept 20, 2023

ION* Biome Sinus

Sept 2019-Sept 2021

Restore Sinus Spray

June 2017-Sept 2019

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumers

  1. Call your doctor right away. Report the use of the recalled medication.
  2. Monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
  3. Consumers with questions may contact the ION* Sinus Recall Team at 1-844-715-0113. They are available Mon-Fri from 9:00 a.m. to 5:00 p.m. (EST). You can also contact them via email at sinusrecall@intelligenceofnature.com.
  4. If you are currently 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 remove stock affected by the recall immediately.
  2. Contact the ION* Sinus Recall Team at 1-844-715-0113 or utilize sinusrecall@intelligenceofnature.com to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
  3. Notify affected consumers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact the ION* Sinus Recall Team at 1-844-715-0113 or utilize sinusrecall@intelligenceofnature.com to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
  3. Notify affected retailers of recalled batches that they have already or will receive.
  4. 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 to the healthcare industry and the general public alike. 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

 

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 reach out to her directly on LinkedIn!

 


Leave a Reply

Your email address will not be published. Required fields are marked *

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