Public advisory - Cromolyn Eye Drops recalled due to risk of infection

OTTAWA, ON, Aug. 4, 2023 /CNW/ -

Summary

Cromolyn Eye Drops 10 mL (CNW Group/Health Canada)

• 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.

Affected products

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

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

Également disponible en français

SOURCE Health Canada

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