Sandoz Eye Solutions Recalled in CanadaJul 21, 2008 | Parker Waichman LLP
Canadian health regulators are warning consumers there to avoid two types of potentially defective prescription eye solution. Sandoz Timolol Ophthalmic Solution in 0.25% strength and Sandoz Timolol Ophthalmic Solution in 0.5% strength have been recalled in Canada because some bottles may contain more of the active ingredient (timolol maleate) than indicated on the label.
The manufacturer, Sandoz Canada Inc., is recalling the products, and Health Canada is continuing to monitor the effectiveness of this recall. A separate communication will be sent by Sandoz to doctors and pharmacists notifying them of the recall.
According to Health Canada, Sandoz Timolol Ophthalmic Solution is used to treat glaucoma, as well as high fluid pressure inside the eye. Exposure to excess timolol maleate could cause users to experience dry eye, eye irritation, inflammation of the eyelids and/or cornea, drooping of the upper eyelid, double vision, dizziness, headache, abnormally slow heartbeat, abnormally low blood pressure, shortness of breath, difficulty breathing, and cardiac failure.
To date, there have been no cases of adverse reactions linked to the use of this product reported in Canada.
Patients using either of the recalled Sandoz Timolol Ophthalmic Solutions should stop using the products and return them to their pharmacy. They should also contact their doctors to insure that of their condition is not interrupted.
Consumers requiring more information about the Sandoz Timolol Ophthalmic Solution recall can contact Health Canada’s at (613) 957-2991, or toll free at 1-866-225-0709.