Accupro Filmtabletten
Recall
|
Medicines
|
22/04/2022
The marketing authorisation holder informed its customers on April 22, 2022, that the nitrosamine levels of the listed batches are above the permitted acceptable daily dose.
For that reason, the affected batches are recalled as a precautionary measure.
| Name of the medicinal product | 1) Accupro 5 mg Filmtabletten 2) Accupro 10 mg Filmtabletten 3) Accupro 20 mg Filmtabletten |
|---|---|
| Marketing authorisation number(s) | 1) 1-19359 2) 1-19361 3) 1-19363 |
| CIP code | 1) 1256173 2) 1256196 3) 1256204 |
| Marketing authorisation holder | Pfizer Corporation Austria GmbH |
| Batch number(s) | 1) Batch, Expiry Date DT1724, 31.12.2022 EJ7143, 31.12.2022 FN5885, 31.05.2024 2) Batch, Expiry Date ET1543, 30.06.2023 FJ1095, 30.06.2024 3) Batch, Expiry Date FG6239, 30.04.2024 |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-3835 |
Further inquiry note
Page last modified:
22/04/2022