Archived – Recall of Sandoz Timolol Ophthalmic Solution 0.25% and Sandoz Timolol Ophthalmic Solution 0.5% due to potential health risk

Starting date:

July 18, 2008

Posting date:

July 18, 2008

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product Safety, Dosage, Labelling and Packaging

Audience:

General Public

Identification number:

RA-110002259

• 
  Media enquiries
• 
  Public enquiries

Health Canada is warning consumers not to use the prescription drug Sandoz Timolol Ophthalmic Solution in 0.25% and 0.5% strengths, because some bottles may contain more of the active ingredient (timolol maleate) than indicated on the label, exposing patients to an increased risk of adverse events.

Sandoz Timolol Ophthalmic Solution 0.25% and 0.5% are eye drops taken for treatment of increased intraocular pressure (high fluid pressure inside the eye) and glaucoma.

Potential adverse events may include red 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.

Patients taking either Sandoz Timolol Ophthalmic Solution 0.25% or 0.5% eye drops should discontinue use and consult their health care practitioner immediately to ensure that treatment of the original condition (intraocular pressure) is not interrupted. Consumers should return the product to their pharmacist for safe disposal.

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.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at 613-957-2991, or toll free at

1-866-225-0709.

To date, there have been no cases of adverse reactions linked to the use of this product reported in Canada. To report a suspected adverse reaction to this product, please contact the Canada Vigilance Program of Health Canada by one of the following methods:

Telephone: 1-866-234-2345

Facsimile: 1-866-678-6789

Canada Vigilance Program

Marketed Health Products Directorate

Ottawa, Ontario, AL 0701C

K1A 0K9

E-mail: CanadaVigilance@hc-sc.gc.ca

The Canada Vigilance adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect™ area of the Health Canada Web site.

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709