Herceptin (Inopha) (2)
Replacement
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Medicines
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22/04/2014
The parallel distributor has informed its supplied customers in a letter dated 18.04.2014 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: INOPHA GmbH |
| Batch number(s) | H4150B01, H4171B01, H4179B02, H4261B01, H4263B02, H4279B01, N1001B01, N1002B02, N1002B03 |
| Classification of the recall | 2 |
| BASG reference number | INS - 640.001 - 1087 |
Further inquiry note
Page last modified:
12/07/2022