All Lots of Sandoz Timolol Ophthalmic Solution 0.25% and 0.5% Recalled

Sandoz Timol and Health Canada Issue Urgent Recall

Sandoz Canada, in consultation with Health Canada, is recalling Sandoz Timolol Ophthalmic Solution 0.25% (DIN 02166712) and 0.5% (DIN 02166720), bottles of 5 mL, 10 mL and 15 mL (products codes 8550, 8560, 8570, 8580, 8590 and 8600) because certain bottles from different lots of these products were found to contain a higher concentration of timolol than the approved labelled specifications. By using the solution at a higher concentration, the maximum recommended dosage of 1 drop twice daily of 0.5% may be exceeded. The possible adverse effects that could be expected are the same as those with therapeutic dosage, however there is a theoretical risk for an increase in severity or frequency. Adverse reactions reported with systemic beta-adrenergic blocking agents may occur with topical administration.

Adverse reactions may occasionally include signs and symptoms of ocular irritation, including conjunctivitis, blepharitis, keratitis, blepharoptosis, and decreased corneal sensitivity. Visual disturbances including refractive changes (due to withdrawal of myotic therapy in some cases), diplopia, and ptosis have been reported infrequently.

Hypersensitivity reactions including localized and generalized rash and urticaria, have been reported rarely. As with other topically applied ophthalmic drugs, this drug may be absorbed systemically. There have been reports of inadvertent overdosage with timolol maleate ophthalmic resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospam and cardiac arrest. It is important to note that these side effects were also reported at therapeutic dosage.

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Published on Jul-25-08