Recall | Medicines | 25/01/2018

The marketing authorization holder informed its supplied customers in a letter dated January 23, 2018, that "Saroten 10mg Film-Coated Tablets" was placed on the market with an incorrect dosage information for the treatment of depressive disorders (episodes of major depression) in the package leaflet. Therefore, the two batches placed on the market in Austria are being recalled.

Name of the medicinal product Saroten 10 mg - Filmtabletten
Marketing authorisation number(s) 11734
Marketing authorisation holder Lundbeck Austria GmbH
Batch number(s) 2554243 und 2558495
Classification of the recall2
BASG reference number INS-640.001-2378

Further inquiry note