Warning
2006-24
May 3, 2006
For immediate release
Health Canada warns consumers about Sandoz Prednisolone 1% Ophthalmic Suspension due
to potential health risk
OTTAWA - Health Canada is warning consumers not to use Sandoz Prednisolone
1% USP ophthalmic suspension eye drops because of the possibility that the bottles may
mistakenly contain another product, Blue Collyrium, raising potentially serious health
risks.
The possibility that the bottle does not contain the correct product was raised when one
bottle from one lot of Prednisolone 1% USP ophthalmic suspension eye drops was found to
contain Blue Collyrium.
Patients who have been prescribed Sandoz Prednisolone 1% USP ophthalmic suspension eye
drops should discontinue use of the product and consult with their physician or health
care practitioner immediately to ensure that treatment of the underlying condition is not
delayed.
As a precautionary measure, patients should also return the product to the place of purchase
and have the pharmacist confirm that the 10 ml white plastic bottle they purchased contains
the right product. Prednisolone 1% USP ophthalmic suspension eye drops are white, while
Blue Collyrium drops are dark blue. It may be difficult to identify colour differences
through the white bottles. This applies to all lots.
The lot number of the product that has been found to contain Blue Collyrium is 128832,
with an expiration date of 2007-10. This lot number can be found on the bottle.
At this time, a recall of the affected lot has been initiated by Sandoz Canada Incorporated.
The product was distributed across Canada to wholesalers, pharmacists and hospitals. Although
this product is not indicated for veterinary use, it has also been distributed to veterinary
wholesalers.
Prednisolone 1% USP ophthalmic suspension eye drops is prescribed in the treatment of
conditions that cause inflammation of the eye and for use after cataract surgery.
If a patient suffers from eye inflammation and uses Blue Collyrium instead of the prescribed
Prednisolone 1% USP ophthalmic suspension eye drops the inflammation will not be treated,
which may lead to severe complications, including damage to eye tissue and scarring.
Blue Collyrium, used to treat eye redness caused by minor irritation, is not recommended
for use for more than 72 hours without consulting a physician. However, Prednisolone 1%
USP ophthalmic suspension eye drops may be used beyond 72 hours. As a result of the product
mix-up, patients would be exposed to Blue Collyrium for a much longer period than recommended.
Blue Collyrium is also not recommended for use in children. Patients with certain medical
conditions, including heart disease, high blood pressure, asthma, diabetes and thyroid
disease may be at higher risk of adverse effects from taking Blue Collyrium. To report
a lack of efficacy of treatment or a suspected adverse reaction to Prednisolone 1% USP
ophthalmic suspension, please contact the Canadian Adverse Drug Reaction Monitoring Program
(CADRMP) of Health Canada by one of the following methods:
Telephone: 866-234-2345
Facsimile: 866-678-6789
CADRMP
Marketed Health Products Directorate
Health Canada
AL 0701C
Ottawa, Ontario, K1A 0K9
Email: cadrmp@hc-sc.gc.ca
Public inquiries about issues raised in this advisory should be directed to Health Canada
at (613) 957-2991 or toll free at 866 225-0709.
-30-
Media Inquiries:
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
1(866) 225-0709
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