Medicine recalls
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| Austrlia: Recall of Zovirax Ophthalmic ointment |
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The Therapeutic Goods Administration (TGA) advised consumers and health professionals that GSK, in consultation with the TGA, was undertaking a recall of unsold Zovirax Ophthalmic ointment (3% aciclovir), which may result in a product shortage for this medicine.
Zovirax Ophthalmic ointment is used to treat herpes simplex virus infections of the cornea of the eye. If untreated, the infection can damage the cornea and this can lead to permanent loss of vision.
GSK is undertaking a retail level recall after metal particles were found in three different lots of the active pharmaceutical ingredient, aciclovir, which was used in 11 batches of Zovirax Ophthalmic ointment. Two of these batches have been supplied in Australia. The size of the metal particles in the raw materials used to manufacture the Zovirax Ophthalmic ointment range in size from 0.15 to 0.85 mm.
The main safety concern with ointments used to treat eye conditions is the risk for metal particulates to physically damage the eye. The risk of metal particles being present in the ointment is low.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/alerts-medicine-zovirax-ophthalmic-ointment-141024.htm#.VEsPmUzyyUk
In Hong Kong, Zovirax Ophthalmic Ointment (HK-17375) is a pharmaceutical product registered by GlaxoSmithKline Ltd (GSK) and is a prescription-only medicine. GSK confirmed with Drug Office that the product is not marketed in Hong Kong. Therefore, the recall in Australia will not affect Hong Kong.
Ends/Saturday, 25 October, 2014
Issued at HKT 12:00 |
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