Public advisory - Cromolyn Eye Drops (5 mL & 10 mL): All lots recalled due to possible risk of infection

OTTAWA, ON, Sept. 25, 2024 /CNW/ -

Summary

Cromolyn Eye Drops, 5 mL & 10 mL formats (CNW Group/Health Canada (HC))

• Product: All lots of Cromolyn Eye Drops, 5 mL & 10 mL formats (DIN 02009277)
• 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.

Images

Affected products

Product	DIN	Lot	Expiry date	UPC
Cromolyn Eye Drops 5 mL	02009277	221021 231034 240517	30-04-2025 30-04-2026 30-11-2026	057606091826
Cromolyn Eye Drops 10 mL	02009277	230728 230729 240210 240211	31-01-2026 31-01-2026 31-08-2026 31-08-2026	057606091833

Issue

The Pendopharm Division of Pharmascience Inc. is recalling all lots of the 5 mL and 10 mL formats 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 (seasonal pink eye) in adults and children five years of age and older.

The company's testing found 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, if they are introduced into the product. In particular, testing found that the preservative may not prevent the growth of  the bacteria Pseudomonas aeruginosa if it is introduced into the product.

For healthy people, the risk of serious eye infections from  eye drops contaminated with microbes is relatively low and an infection may resolve on its own. If the infection does not resolve on its own, it could often be treated with topical antibiotics. Signs of infection may include eye pain, changes in vision, light sensitivity, redness of the eye, excessive discharge and abnormal pupils. 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.

In addition to the health risks outlined above, Pseudomonas aeruginosa can cause serious infections for people whose immune system has been weakened by a serious condition, especially cystic fibrosis, HIV/AIDS, severe lung disease, cancer, diabetes or burns. These infections include pneumonia, bone infections, urinary tract infections, gastrointestinal infections, meningitis and blood infections.

Health Canada is monitoring the company's recall and investigation, including its implementation of corrective and preventative actions to stop this issue from reoccurring. The Department will inform the public if any new health risks are identified.

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 [email protected] if you have questions about this recall.
• Report any health product-related side effects or complaints to Health Canada.

Additional information

Previous recalls or alerts

• Advisory: Cromolyn Eye Drops recalled due to risk of infection (2023-08-04)

Également disponible en français

SOURCE Health Canada (HC)

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709, [email protected]