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Health Canada issues warning about prednisolone ophthalmic solution 1%
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OTTAWA — Health Canada has warned consumers that two lots of prednisolone ophthalmic solution 1% may contain particles that could lead to increased eye irritation, the agency announced.
Accordingly, Ratiopharm Inc., the distributor of the solution in Canada, has voluntarily recalled all units from lot No. HF26 and lot No. HF27, according to a press release from Health Canada.
Manufactured by Allergan under the brand name Pred Forte, prednisolone ophthalmic solution 1% eye drops are indicated for treating eye inflammation. Patients using the affected lots may observe particles in the bottle and experience difficulty extracting the solution due to blockage.
According to the release, potential adverse events may include a coarse feeling in the eye or irritation that could lead to corneal abrasion.
Allergan has determined that the two affected lots were not temperature-controlled before shipment to Canada and has assured Ratiopharm that measures have been taken to ensure appropriate temperature control during transportation of the eye drops, the release said.
Health Canada has warned consumers not to expose the eye drops to significant temperature changes, as doing so could lead to clumping that could result in visible particles.
As of press time, one case of blurry vision associated with use of the eye drops has been reported in Canada.
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