Eye drops recalled in Canada over infection risk

The 5 mL and 10 mL packs of Cromolyn Eye Drops are being recalled. (Government of Canada)

A Canadian pharmaceutical company is warning consumers not to use some of its eye drops because of potential microbial growth that may result in eye infections.

Montreal-based Pendopharm, a division of Pharmascience Inc., is recalling the 5 mL and 10 mL packs of its Cromolyn Eye Drops, with the Drug Identification Number 02009277. The products have the following expiry dates: April 30, 2025; April 30, 2026; Nov. 30, 2026; Jan. 31, 2026; and Aug. 31, 2026.

"Children, pregnant people, seniors and people with weaker immune systems may be more susceptible to infection or 'complications from microbial contamination,'" according to a public advisory Wednesday on the Canadian government's website.

On the other hand, for healthy individuals, the risk of developing serious eye infections from potentially contaminated eye drops is "relatively low" and the infection may even heal on its own, read the advisory.

The specialty pharmaceutical company advises consumers to return the product to a pharmacy, which will properly dispose it.

"Consult a health care professional if you have used this product and have health concerns," the advisory added.

Those who want to contact the company can reach Pendopharm by calling 1-888-550-6060 or emailing [e-mail].

As well, individuals can report any side-effects or complaints to Health Canada.

Product testing

The product is an over-the-counter drug meant to prevent and alleviate symptoms of seasonal allergic conjunctivitis, a common type of eye allergy and form of pink eye, in adults and children five and older.

The public advisory stated that company testing found the products' preservative may not be as effective as expected, increasing the risk of microbes like moulds or bacteria growing. It cited particular concern about the risk of the bacteria Pseudomonas aeruginosa contaminating the product.

Symptoms and treatment

Individuals may have infections if they experience eye pain, changes in vision, light sensitivity, eye redness, excessive discharge and abnormal pupils, according to the advisory.

For severe but rare cases, the infections may lead to vision loss, systemic infections and death.

"This risk is higher for people more susceptible to infection," the advisory read.

For serious cases, the infection can often be treated with topical antibiotics, it added.

In addition, the bacteria Pseudomonas aeruginosa can cause serious infections for individuals whose immune system has been weakened by serious conditions including cystic fibrosis, HIV-AIDS, severe lung disease, cancer, diabetes or burns. Those with serious infections may experience pneumonia, bone infections, urinary tract infections, gastrointestinal infections, meningitis and blood infections.

The advisory says that Health Canada is monitoring the situation, including the company's "implementation of corrective and preventative actions."

"The Department will inform the public if any new health risks are identified," according to the public advisory.