Zovirax Ophthalmic ointment

Retail level recall - potential for eye damage

6 June 2016

Update 3 - registered product now available

The sponsor of Zovirax Ophthalmic ointment (3% aciclovir), GlaxoSmithKline Australia, has advised that the manufacturing issue that resulted in the recall and subsequent medicine shortage has been resolved.

The registered product is now available through the normal supply chains.

The unapproved products listed below that were available as alternatives due to the shortage are no longer available under section 19A of the Therapeutic Goods Act 1989.

Update 2 - alternative product now available

20 April 2015

  • AciVision 30 mg/g Aciclovir eye ointment can be obtained by contacting Medsurge Pty Ltd by phone on 1300 788 261 or email at sales@medsurge.com.au.
  • Virgan 0.15% w/w ganciclovir eye gel can be obtained by contacting HL Pharma by phone on 03 9823 6228 or email at orders@hlpharma.com.au.

Any adverse events involving AciVision 30 mg/g Aciclovir eye ointment should be reported to Medsurge; and any adverse events involving Virgan 0.15% w/w ganciclovir should be reported to HL Pharma.

Alternatively, adverse events can be reported directly to the TGA at Report an adverse event to a medicine.


Update - alternative product now available

25 February 2015

Consumers and health professionals are advised that an alternative ophthalmic (eye) treatment is now available to address the shortage resulting from the below recall.

AciVision 30 mg/g Aciclovir ointment has been granted TGA authorisation to be supplied temporarily in lieu of Zovirax Opthalmic ointment (3% aciclovir) for the treatment of keratitis of the eye caused by herpes simplex virus.

Alternative products had previously only been available in Australia through the Special Access Scheme (SAS). There is no need to use the SAS to supply AciVision 30 mg/g Aciclovir ointment now the arrangements described above are in place.

Consumers can take their prescription for aciclovir ophthalmic ointment to their pharmacy as normal.


Zovirax Ophthalmic ointment

24 October 2014

Consumers and health professionals are advised that GSK, in consultation with the TGA, is undertaking a recall of unsold Zovirax Ophthalmic ointment (3% aciclovir), which will 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 affected batch numbers are 3L942 (expiring October 2015) and 4B909 (expiring February 2016). The size of the metal particles in the raw materials used to manufacture the Zovirax Ophthalmic ointment range in size from 0.15 to 0.875 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.

This issue will result in a product shortage for this medicine and there are no alternative topical treatments currently available in Australia. The TGA is working with sponsors to arrange supply of alternative treatments and health professionals can apply to import an alternative treatment for an individual patient through the Special Access Scheme.

No other Zovirax branded products are affected by this issue.

Information for consumers

All unsold Zovirax Ophthalmic ointment that may be affected by this issue is being recalled from retailers.

If you have been prescribed Zovirax Ophthalmic ointment, do not stop using it without first talking to a health professional. The consequences of interrupting your treatment may outweigh the risk of the potential exposure to metal particles from your Zovirax Ophthalmic ointment.

If you have been diagnosed with a herpes simplex virus infection of the eye and your vision is deteriorating you should contact your ophthalmologist.

If you have any questions or concerns about this issue, talk to your ophthalmologist or other health professional.

Information for all health professionals

GSK is in the process of contacting Australian health professionals to inform them of this recall.

If you are treating a patient who has been prescribed Zovirax Ophthalmic ointment, advise them of this issue. Reassure them that the consequences associated with interrupting their treatment may outweigh the risk of the potential exposure to metal particles from their Zovirax Ophthalmic ointment.

If they continue to have any questions or concerns about this issue, refer them to their ophthalmologist.

Information for ophthalmologists

GSK is in the process of contacting Australian health professionals to inform them of this recall.

If you are treating a patient who has been prescribed Zovirax Ophthalmic ointment, advise them of this issue. Reassure them that the consequences associated with interrupting their treatment may outweigh the risk of the potential exposure to metal particles from their Zovirax Ophthalmic ointment.

This issue will result in a product shortage for this medicine. Alternative topical treatments include ganciclovir gel 0.15%, trifluridine 1% and vidarabine, but none of these are currently approved for use in Australia. You can apply to import an alternative treatment for an individual patient through the Special Access Scheme.

The TGA is also working with sponsors to arrange supply of alternative topical treatments.

Oral aciclovir is an alternative to topical treatment, however, it is not registered for this indication.

Both oral aciclovir and alternative topical treatments are not subsidised under the Pharmaceutical Benefits Scheme.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.