Ircal and Refresh Night Time eye ointments

Recall - potential for particle contamination

29 September 2015

Consumers and health professionals are advised that Allergan, in consultation with the TGA, is recalling certain batches of Ircal and Refresh Night Time eye ointments due to the potential for particle contamination.

These eye ointments are used to provide temporary relief from dry eyes.

There have been reports of small particles of black plastic being ground off the lids of some ointment tubes when opening, with the potential for these particles to be introduced into the ointment. If these particles were to be introduced into the eye there is the potential for discomfort, irritation, pain, swelling or abrasion.

Ircal 2 x 3.5 g ointment container and packaging
Ircal
2 x 3.5 g ointment
Refresh Night Time 1 x 3.5 g ointment
Refresh Night Time
1 x 3.5 g ointment
Refresh Night Time 2 x 3.5 g ointment
Refresh Night Time
2 x 3.5 g ointment

The affected batches are:

  • Ircal 2 x 3.5 g ointment
    • 86908 (expiry date 12/17)
  • Refresh Night Time 1 x 3.5 g ointment
    • 85422 (expiry date 06/17)
    • 86516 (expiry date 09/17)
    • 87052 (expiry date 11/17)
    • 87437 (expiry date 02/18)
  • Refresh Night Time 2 x 3.5 g ointment
    • 84683 (expiry date 04/17)
    • 85422 (expiry date 06/17)
    • 85432 (expiry date 06/17)
    • 86514 (expiry date 09/17)
    • 86934 (expiry date 12/17).

Only the batches listed above are affected by this issue.

Information for consumers

If you or someone you care for is using Ircal or Refresh Night Time eye ointment, please be aware of this issue.

If you have Ircal or Refresh Night Time eye ointment, check the batch number (displayed on the bottom of the carton and on the crimp of the tube).

If you have ointment from one of the affected batches, return it to the place of purchase for refund or replacement. In the meantime do not use the ointment.

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

Information for health professionals

If you are treating a patient who is using either Ircal or Refresh Night Time eye ointment, advise them of this issue and instruct them to check the packaging and/or tube for the batch number.

If they have ointment from one of the affected batches listed above, advise them to return it to the place of purchase for refund or replacement.

Information for pharmacists

Allergan has written to pharmacists advising them of this issue and providing instructions regarding the recall process.

Pharmacists should quarantine any affected stock and return it to their wholesaler.

If you have any questions or concerns about this issue, contact Allergan customer service on 1800 252 224 or email AustraliaEnquiries@Allergan.com.

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.