Recall | Medicines | 31/01/2013

The distributor informed its supplied customers that during stability tests after a storage period of more than two years the specifications of the product could not be met. An impurity - "Desloratadine Citric Amide" - was detected. As the batches on the market have not yet reached a shelf life of two years, but have a total shelf life of three years, a precautionary recall is being carried out.

Name of the medicinal product Desloratadine ratiopharm 5 mg Filmtabletten
Marketing authorisation number(s) EU/1/11/746/002, 006
Marketing authorisation holder ratiopharm GmbH, DE

Vertrieb und Durchführung Rückruf:
ratiopharm Arzneimittel Vertriebs-GmbH, AT
Batch number(s) EU/1/11/746/002, 10 Tabletten:
14041912, 14078012, 14115512

EU/1/11/746/006, 30 Tabletten:
14042012, 14077912, 14078012, 14117612, 14157512
Classification of the recall 2
BASG reference number INS-640.001-0650

Further inquiry note