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
Email

Further inquiry note