The Pendopharm Division of Pharmascience Inc. is recalling all lots of the 5 mL and 10 mL formats 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 (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 molds or bacteria, if they are introduced into the product. In particular, testing found that the preservative may not prevent the growth of the bacteria Pseudomonas aeruginosa if it is introduced into the product. For healthy people, the risk of serious eye infections from eye drops contaminated with microbes is relatively low and an infection may resolve on its own. If the infection does not resolve on its own, it could often be treated with topical antibiotics. Signs of infection may include eye pain, changes in vision, light sensitivity, redness of the eye, excessive discharge and abnormal pupils. 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. 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. These infections include pneumonia, bone infections, urinary tract infections, gastrointestinal infections, meningitis and blood infections. Health Canada is monitoring the company's recall and investigation, including its implementation of corrective and preventative actions to stop this issue from reoccurring. The Department will inform the public if any new health risks are identified.
RecallTracker