OTTAWA,
ON, Sept. 25, 2024 /CNW/ -
Summary
- Product: All lots of Cromolyn Eye Drops, 5 mL & 10
mL formats (DIN 02009277)
- Issue: Health products - Product safety
- What to do: Do not use the affected product. Return it
to your local pharmacy for proper disposal. Consult a health care
professional if you have used this product and have health
concerns.
Images
Affected products
Product
|
DIN
|
Lot
|
Expiry
date
|
UPC
|
Cromolyn Eye Drops 5
mL
|
02009277
|
221021
231034
240517
|
30-04-2025
30-04-2026
30-11-2026
|
057606091826
|
Cromolyn Eye Drops 10
mL
|
02009277
|
230728
230729
240210
240211
|
31-01-2026
31-01-2026
31-08-2026
31-08-2026
|
057606091833
|
Issue
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.
What you should do
- Do not use the affected product. Return it to your local
pharmacy for proper disposal.
- Consult a health care 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 medinfo@pendopharm.com if you have
questions about this recall.
- Report any health product-related side effects or complaints to
Health Canada.
Additional information
Previous recalls or alerts
- Advisory: Cromolyn Eye Drops recalled due to risk of infection
(2023-08-04)
Également disponible en français
SOURCE Health Canada (HC)