Ultracortenol eye drops
Recall
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Medicines
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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 |
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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 recall | 2 |
BASG reference number | INS-640.001-1652 |
Further inquiry note
Page last modified:
12/07/2022