2023-08-06 17:42:00
Health Canada issued a recall on August 24 regarding Cromolyn eye drops due to an infection risk.
This recall involves all lots of Cromolyn Eye Drops, 10ml (DIN 02009277). To find out more regarding batch numbers, their expiry date and their UPC, go to ici.
ISSUE
Pendopharm, a division of Pharmascience Inc., is recalling all lots of Cromolyn Eye Drops 10ml packages due to a risk of microbial growth. Using a product contaminated with germs can lead to eye infection. Children, pregnant people, seniors and people with weakened immune systems may be more susceptible to infection or developing complications from microbial contamination.
Cromolyn eye drops are an over-the-counter medication used to prevent and relieve symptoms of seasonal allergic conjunctivitis in adults and children five years of age and older.
According to company testing, the preservative used in the product may be less effective than expected, which might increase the risk of microbes, such as mold or bacteria, growing over time. they penetrate the product.
For healthy people, the risk of serious eye infections from contaminated eye drops is relatively low and any infection may clear up on its own. If the infection does not clear up on its own, it can often be treated with topical antibiotics. In rare cases, eye infections can have serious consequences, including loss of sight, systemic infections and death. This risk is accentuated in people most susceptible to infections. Eye pain, vision changes, sensitivity to light, redness of the eye, excessive discharge, and abnormal pupils are all signs of infection.
Although the growth of other microbes is possible, testing has revealed that the preservative may not prevent the growth of a particular type of bacteria called Pseudomonas aeruginosa if introduced into the product. In addition to the risks mentioned above, the bacteria can cause serious infections (eg pneumonia, bone infections, urinary tract infections, gastrointestinal infections, meningitis or blood infections) in people whose immune system is weakened by other serious conditions, especially cystic fibrosis, HIV infection or AIDS, acute lung disease, cancer, diabetes or burns.
WHAT TO DO
Do not use the affected product. Return it to your pharmacy for proper disposal.
Consult a healthcare practitioner if you have used this product and are concerned regarding your health.
Contact Pendopharm, a division of Pharmascience Inc., by calling 1-888-550-6060, or by emailing [email protected]if you have any questions regarding this recall.
Report any side effects or health product complaints to Health Canada.
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