Public advisory

Cromolyn Eye Drops recalled due to risk of infection

Last updated

Summary

Product
Cromolyn Eye Drops 10 mL (DIN 02009277) – all lots
Issue
Health products - Product safety
What to 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.

Distribution
National

Affected products

 
Product DIN Lot Expiry date UPC
Cromolyn Eye Drops 10 mL 02009277 210101 31-07-2023 057606360748
Cromolyn Eye Drops 10 mL 02009277 210207 31-08-2023 057606360748
Cromolyn Eye Drops 10 mL 02009277 210516 30-11-2023 057606091833
Cromolyn Eye Drops 10 mL 02009277 210722 31-01-2024 057606091833
Cromolyn Eye Drops 10 mL 02009277 210723 31-01-2024 057606091833
Cromolyn Eye Drops 10 mL 02009277 211026 30-04-2024 057606091833
Cromolyn Eye Drops 10 mL 02009277 211232 30-06-2024 057606091833
Cromolyn Eye Drops 10 mL 02009277 220206 31-08-2024 057606091833
Cromolyn Eye Drops 10 mL 02009277 220310 30-09-2024 057606091833
Cromolyn Eye Drops 10 mL 02009277 220715 31-01-2025 057606091833
Cromolyn Eye Drops 10 mL 02009277 221022 30-04-2025 057606091833
Cromolyn Eye Drops 10 mL 02009277 221125 31-05-2025 057606091833
Cromolyn Eye Drops 10 mL 02009277 221232 30-06-2025 057606091833

Issue

The Pendopharm Division of Pharmascience Inc. is recalling all lots of the 10 mL format of Cromolyn Eye Drops due to the risk of microbial growth. Using a product contaminated with microbes may lead to an eye infection. Children, pregnant people, seniors and people with weaker immune systems may be more susceptible to infection or complications from microbial contamination.

Cromolyn Eye Drops is an over-the-counter drug used to prevent and relieve symptoms of seasonal allergic conjunctivitis (commonly known as pink eye) in adults and children five years of age and older.

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.

For healthy people, the risk of serious eye infections due to contaminated eye drops is relatively low and any infection may resolve on its own. If the infection does not resolve on its own, it would often be treatable with topical antibiotics. In rare cases, eye infections can lead to severe outcomes including vision loss, systemic infections, and death. This risk is higher for people more susceptible to infection. Signs of infection may include eye pain, changes in vision, light sensitivity, redness of the eye, excessive discharge and abnormal pupils.

While the growth of other microbes may be possible, 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. In addition to the risks outlined above, for people whose immune system has been weakened by a serious condition, 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
Distribution
National
Identification number
RA-74063
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