Public advisory

Rhinaris Nasal Mist: One lot recalled due to risk of microbial growth which may lead to infection

Last updated

Summary

Product
Rhinaris Nasal Mist 30 mL (lot 230391A)
Issue
Health products - Product safety
What to do

Do not use the affected product. Return it to your local pharmacy for proper disposal.

Affected products

Product DIN Lot Expiry date UPC
Rhinaris Nasal Mist 30 mL 02354551 230391A 31-05-2025 5760622302

Issue

The Pendopharm Division of Pharmascience Inc. is recalling one lot of Rhinaris Nasal Mist due to the risk of microbial growth. Using a product contaminated with microbes may lead to rhinosinusitis (a sinus infection). Children, pregnant people, seniors and people with weaker immune systems may be more susceptible to infection or complications from microbial contamination.

Rhinaris Nasal Mist is an over-the-counter drug used to moisturize and lubricate dry nasal passages in adults and children at least two years of age.

The company's testing showed that the preservative in the product may not be as effective as expected, which could lead to an increased risk of growth of microbes such as molds or bacteria over time if they are introduced into the product.

Although rare, rhinosinusitis can lead to more serious complications, such as nasal abscesses (a collection of pus), cellulitis (skin infection) or meningitis (infection and inflammation of the fluid and membranes surrounding the brain and spinal cord).

While the growth of other microbes may be possible, the testing showed that the preservative may not prevent the growth of a specific type of bacteria called Pseudomonas aeruginosa if it is introduced into the product. For someone whose immune system has been weakened by other serious conditions, especially cystic fibrosis, HIV/AIDS, severe lung disease, cancer, diabetes, or burns, Pseudomonas aeruginosa can cause serious infections including pneumonia, bone infections, urinary tract infections, gastrointestinal infections, meningitis, and blood infections.

What you should do

  • Do not use the affected product. Return it to your local pharmacy for proper disposal.
  • Consult a health care professional if you have used this product and have health concerns.
  • Contact Pendopharm Division of Pharmascience Inc. by calling 1-888-550-6060 or emailing medinfo@pendopharm.com if you have questions about this recall.
  • Report any health product-related side effects or complaints to Health Canada.

Additional information

Details
Original published date:
Alert / recall type
Public advisory
Category
Health products - Drugs
Companies
Published by
Health Canada
Audience
General public
Identification number
RA-73927
Media and public enquiries

Media Enquiries:
Health Canada
613-957-2983
media@hc-sc.gc.ca

Public Enquiries:
613-957-2991
1-866-225-0709
info@hc-sc.gc.ca