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Health Canada is recalling a brand of eye drops, saying use of the product may cause microbial growth, leading to the risk of an eye infection.
The recall is for Cromolyn Eye Drops, an over-the-counter drug used to relieve symptoms of allergy-induced pink eye in adults and children aged five and older.
Health Canada described in its recall a risk of microbial growth of a bacteria called pseudomonas aeruginosa, which can lead to an eye infection.
According to the notice issued Friday, the recall is for all 10-mililitre formats of Cromolyn Eye Drops.
The recall was issued after the Pendopharm division of Pharmascience Inc. tested the product’s preservative and found it to be not “as effective as expected,” leading to an increased risk of moulds and bacteria, says the health agency.
Health Canada says eye infections due to contaminated eye drops are treatable, but that severe outcomes are possible for people susceptible to infection.
For those whose immune systems have been weakened by conditions including cancer, HIV/AIDS and diabetes, pseudomonas aeruginosa can cause serious infections including pneumonia and bone infections, as well as blood and gastrointestinal infections, and meningitis.
In rare cases, vision loss and death are possible, but Health Canada says the risk of any serious outcome for healthy people is “relatively low” – to the point where the agency says infections caused by the eye drops may even go away on their own
Signs of infection may include eye pain, changes in vision, light sensitivity, redness of the eye, excessive discharge and abnormal pupils, says Health Canada.
Health Canada urges Canadians to stop using the recalled products and return them to their local pharmacies for proper disposal, and to consult a health-care professional if there are any health concerns.
Any side effects or complaints should be reported to Health Canada.
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