Other safety alerts
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| Canada: Cosopt (dorzolamide hydrochloride/timolol maleate) Preservative-Free Ophthalmic Solution - Risk of Eye Injury |
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Merck Canada Inc., in consultation with Health Canada, alerts the healthcare professionals about the potential risk of eye injury that can occur due to a change in the design of the unit dose pipette for COSOPT® Preservative-Free Ophthalmic Solution and to provide instructions for appropriate administration. The design of the unit dose pipette has been modified from a conical tip to a new tip with fins that includes plastic left in place after the tab is twisted off. Health Canada is aware of 9 reports of eye injury that may be associated with the use of the fin-tipped pipette. Merck Canada Inc. is working to introduce to the market a new revised pipette design later in 2014. In the interim, Merck Canada Inc. has introduced a warning sticker on the outer carton and updated the instructions in the product information.
Please refer to the following website in Health Canada for details:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../37909a-eng.php
In Hong Kong, the above product is not a registered pharmaceutical product. Related news has been release by MHRA and was posted on the Drug Office website on 29 Jan 2014.
Ends/ Saturday, Feb 8, 2014
Issued at HKT 12:00
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