Herceptin (Inopha)

Replacement | Medicines | 16/04/2014

The parallel distributor has informed its supplied customers in a letter dated 16.04.2014 that Herceptin in Italian presentation has been adulterated and introduced into the legal distribution chain. Therefore, a recall of the above mentioned Italian batches, which were marketed in parallel distribution in Austria, will now be carried out.

Name of the medicinal product Herceptin 150 mg Pulver zur Herstellung eines Infusionslösungskonzentrats
Marketing authorisation number(s) EU/1/00/145/001
Marketing authorisation holder Roche Registration Limited

Paralleldistribution und Durchführung Rückruf:
Batch number(s) H4271B01, H4284B04, H4303B01, H4301B09, H4324B03, H4329B01
Classification of the recall2
BASG reference number INS - 640.001 - 1087

Further inquiry note