Busilvex
Replacement
|
Medicines
|
25/11/2011
The distributor has informed the supplied institutional pharmacies in a letter dated November 25, 2011, that a GMP inspection of the manufacturer Ben Venue Laboratories (BVL) in Ohio/USA has identified deficiencies in quality assurance. As a precautionary measure, all batches of Busilvex manufactured at BVL are now being recalled and replaced with product from an alternative manufacturer.
| Name of the medicinal product | Busilvex 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung |
|---|---|
| Marketing authorisation number(s) | EU/1/03/254/002 |
| Marketing authorisation holder | Pierre Fabre Médicament Vertrieb & Durchführung Austausch: AOP Orphan Pharmaceuticals AG |
| Batch number(s) | 013018B_1 013019B_2, 013019B_3 025212B, 025212B_1 055597B, 055597B_A 797783B 852752B_1 852753B 859739B_1 |
| Expiry date | 09/04/2019 |
| Classification of the recall | 2 |
| BASG reference number | INS-640.001-0294 |
Further inquiry note
Page last modified:
12/07/2022