Pharmacy/Wholesaler level recall of two batches of Zovirax® Ophthalmic Ointment (aciclovir 3%)
27 October 2014
GSK Australia, in consultation with the Therapeutic Goods Administration (TGA), is initiating a voluntary pharmacy/wholesaler level recall of two batches of Zovirax® Ophthalmic Ointment (aciclovir 3%).
Zovirax® Ophthalmic Ointment is used to treat herpes simplex virus infections of the cornea of the eye.
GSK is undertaking the voluntary recall after metal particles outside of the specification limit were found in three lots of the active pharmaceutical ingredient, aciclovir, which was used to manufacture 11 batches of Zovirax Ophthalmic Ointment. Two of these batches have been supplied in Australia.
The implicated batches of Zovirax Ophthalmic Ointment are listed below. No other batches or Zovirax dose forms are implicated.
|3L942||Oct - 2015|
|4B909||Feb - 2016|
GSK is conducting a thorough investigation and appropriate actions are being identified to ensure this does not occur again.
As a result of this recall, supply of Zovirax Ophthalmic Ointment is constrained. This will result in low or no stock availability at dispensing pharmacies. We anticipate supply to resume in Q2 2015.
If you have any questions or concerns about this issue, talk to your ophthalmologist or other health professional.
GSK sincerely regrets the inconvenience that this recall may cause to patients, pharmacists and doctors.
For more information, please contact 1800 064 162.
For media enquiries please contact:
Kim Pickworth, Communications Manager Pharmaceuticals
0477 322 431