Recall | Medicines | 21/10/2014

The marketing authorization holder informed its supplied customers in a letter dated October 21, 2014, that the affected finished product lot 4E915 was produced with an aciclovir active ingredient lot that does not meet the specifications regarding particle size. Because the amount and size of potential metallic particles in the finished product lot cannot be estimated and there is a risk that the particles in the ophthalmic ointment could cause eye damage, a precautionary recall is being issued.

This recall will result in a distribution restriction, see also http://www.basg.gv.at/news-center/news/news-detail/article/-68d5c3f62e/.

Name of the medicinal product Zovirax 3% - Augensalbe
Marketing authorisation number(s) 1-18042
Marketing authorisation holder GlaxoSmithKline Pharma GmbH
Batch number(s) 4E915
Classification of the recall2
BASG reference number INS - 640.001 - 1246

Further inquiry note