Desloratadine
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
Page last modified:
12/07/2022