Ultracortenol eye drops

Recall | Medicines | 24/02/2016

Agepha Pharma has informed its customers in a letter dated 24.02.2016 about the recall of the mentioned batch for the following reason: The composition of the eye drops has been changed (addition of povidone), but the official assessment of this change has not been made. The labeling, technical and directions for use do not correspond to the actual product.

Name of the medicinal product Ultracortenol 0,5 % - Augentropfen
Marketing authorisation number(s) 10319
Marketing authorisation holder Agepha Pharma sro, Dial nicna cesta 5, 90301 Senec, Slowakei
Batch number(s) 15JQ203
Classification of the recall2
BASG reference number INS-640.001-1652

Further inquiry note