Velcade
Recall
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Medicines
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22/12/2011
In a letter dated December 12, 2011, the distribution partner informed the institutional pharmacies supplied that the marketing authorization holder was recalling those batches of "Velcade" that were produced at the manufacturer Ben Venue Laboratories (BVL) in Ohio/USA, because deficiencies in quality assurance were identified during a GMP inspection. Consequently, the batches distributed in Austria in parallel were also recalled.
| Name of the medicinal product | Velcade 3,5 mg Pulver zur Herstellung einer Injektionslösung |
|---|---|
| Marketing authorisation number(s) | EU/1/04/274/001 |
| Marketing authorisation holder | Janssen-Cilag International NV Paralleldistribution: HAEMATO PHARM AG Vertrieb & Durchführung Rückruf: AXELERIS Pharma GmbH |
| Batch number(s) | AGZSH00, AIZTY00 |
| Classification of the recall | 2 |
| BASG reference number | INS-640.001-0313 (Dieser Rückruf wurde ohne vorherige/gleichzeitige Meldung an das Bundesamt für Sicherheit im Gesundheitswesen bekannt gemacht) |
Further inquiry note
Page last modified:
12/07/2022