Recall | Medicines | 03/12/2018

The marketing authorization holder informed its supplied customers in a letter dated December 3, 2018, that there are increased reports of side effects for the two batches 180619 and 180620, which refer to "severe burning sensation in the eye". The batches correspond in terms of quality, but are being recalled as a precaution due to the side effect reports.

Name of the medicinal product Prednifluid 10 mg/ml Augentropfensuspension
Marketing authorisation number(s) 135756
Marketing authorisation holder Dermapharm GmbH
Batch number(s) 180619, 180620
Classification of the recall3
BASG reference number INS-640.001-2711

Further inquiry note