Health Canada Issues Warning that Mislabeled Bottles of Sandoz Prednisolone 1% Ophthalmic Suspension Pose a Serious Risk of Eye Damage

Health Canada has issued a warning to consumers not to use Sandoz Prednisolone 1% USP ophthalmic suspension eye drops because of the possibility that the bottles may mistakenly contain Blue Collyrium another product that raises “potentially serious health risks.”

The problem was discovered when one bottle from one lot of Prednisolone 1% USP ophthalmic suspension eye drops was found to contain Blue Collyrium.

All patients who have been prescribed Sandoz Prednisolone 1% USP ophthalmic suspension eye drops are being advised to “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 an additional precautionary measure, patients are also being advised to 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 color differences through the white bottles, however.

Although the lot number of the product that has been found to contain Blue Collyrium is 128832, with an expiration date of 2007-10, all lot numbers are included in the warning. (This lot number can be found on the bottle.)

A voluntary recall of the affected lot has been initiated by Sandoz Canada Incorporated.

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.

According to Health Canada: “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 is used to treat eye redness caused by minor irritation and is not recommended for use for more than 72 hours without consulting a physician.

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.”