Cromolyn Eye Drops recalled due to risk of infection

The Pendopharm Division of Pharmascience Inc. is recalling all lots of the 10 mL format 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 (commonly known as pink eye) in adults and children five years of age and older.

The company's testing showed 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 over time if they are introduced into the product.

For healthy people, the risk of serious eye infections due to contaminated eye drops is relatively low and any infection may resolve on its own. If the infection does not resolve on its own, it would often be treatable with topical antibiotics. 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. Signs of infection may include eye pain, changes in vision, light sensitivity, redness of the eye, excessive discharge and abnormal pupils.

While the growth of other microbes may be possible, testing showed that the preservative may not prevent the growth of a specific type of bacteria called Pseudomonas aeruginosa if it is introduced into the product. In addition to the risks outlined above, for people whose immune system has been weakened by a serious condition, especially cystic fibrosis, HIV/AIDS, severe lung disease, cancer, diabetes or burns, Pseudomonas aeruginosa can cause serious infections including pneumonia, bone infections, urinary tract infections, gastrointestinal infections, meningitis and blood infections.