If you use eye drops, you should be aware of this new Health Canada recall.
The public health agency has issued a recall notice on all lots of 5 mL and 10 mL Cromolyn Eye Drops produced by Pendopharm Division of Pharmascience Inc.
According to the notice, using the eye drops may lead to an eye infection due to risk of microbial growth.
“Children, pregnant people, seniors and people with weaker immune systems may be more susceptible to infection or complications from microbial contamination,” it reads.
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 moulds or bacteria, if they are introduced into the product,” explained Health Canada.
“In particular, testing found that the preservative may not prevent the growth of the bacteria Pseudomonas aeruginosa if it is introduced into the product.”
Here are the affected products and their UPC codes:
Health Canada
The agency says that the risk of serious eye infections from eye drops contaminated with microbes is relatively low for healthy people. An infection may heal on its own.
However, if the infection doesn’t go away on its own, it could be treated with topical antibiotics.
According to Health Canada, signs of infection may include eye pain, changes in vision, light sensitivity, redness of the eye, excessive discharge and abnormal pupils.
It adds that in rare cases, eye infections can lead to severe outcomes including vision loss, systemic infections, and death. This risk is higher for people who are 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,” reads the notice.
These infections include pneumonia, bone infections, urinary tract infections, gastrointestinal infections, meningitis and blood infections.
Health Canada advises users of the eye drops to do the following:
- Do not use the affected product. Return it to your local pharmacy for proper disposal
- Consult a healthcare 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
The agency says it’s monitoring the company’s recall and investigation, including its implementation of corrective and preventative actions to stop the issue from happening again.
The department will inform the public if any new health risks are identified.