Velcade
Recall
|
Medicines
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28/11/2011
The marketing authorization holder has informed the supplied customers by letter dated November 28, 2011, that a GMP inspection of the manufacturer Ben Venue Laboratories (BVL) in Ohio/USA identified quality assurance deficiencies. As a precautionary measure, all batches of Velcade manufactured at BVL are now being recalled. Velcade 3.5 mg can be replaced with product from alternative manufacturers, but Velcade 1 mg will not be available for an extended period.
| Name of the medicinal product | 1. Velcade 3,5 mg Pulver zur Herstellung einer Injektionslösung 2. Velcade 1 mg Pulver zur Herstellung einer Injektionslösung |
|---|---|
| Marketing authorisation number(s) | 1. EU/1/04/274/001 2. EU/1/04/274/002 |
| Marketing authorisation holder | Janssen-Cilag International NV Durchführung Austausch: Janssen-Cilag Pharma GmbH |
| Batch number(s) | 1. Velcade 3,5 mg Pulver zur Herstellung einer Injektionslösung: 9AZSY01,9CZTF00,9DZSB00, AGZSH01, AIZTY00, BDZS300 2. Velcade 1 mg Pulver zur Herstellung einer Injektionslösung: AAZTE00, AAZTE01, AAZTE02, AAZTE03, ACZXB00, ACZXB01, ACZXB02, ACZXC01, ACZXC02, ADZVY00, ADZVY01, ADZVY02, ADZVY03, ADZVY04, AEZTA00, AEZTA01, BFZSW00, BFZSW01 |
| Classification of the recall | 2 |
| BASG reference number | INS-640.001-0293 |
Further inquiry note
Page last modified:
12/07/2022