Binocrit Injektionslösung in einer Fertigspritze
The marketing authorisation holder informed its customers by July 28, 2020 that stability testing showed a deviation which may result in a reduced efficacy of two Binocrit batches. So both affected batches of "Binocrit 20.000 I.E./0,5 ml Injektionslösung in einer Fertigspritze" and "Binocrit 30.000 I.E./0,75 ml Injektionslösung in einer Fertigspritze" are recalled precautionary.
Please note, batch numbers and CIP codes (CIP) have been corrected and are as follows:
"Binocrit 20.000 I.E./0,5 ml Injektionslösung in einer Fertigspritze", batch number 1911190118, CIP 3902163
"Binocrit 30.000 I.E./0,75 ml Injektionslösung in einer Fertigspritze", batch number 1906120007, CIP 3902186
Status 22.09.2020:
Extension of the recall by one batch: "Binocrit 20.000 I.E./0,5 ml Injektionslösung in einer Fertigspritze", batch number 1907080054, CIP 3902163
| Name of the medicinal product | 1. Binocrit 20.000 I.E./0,5 ml Injektionslösung in einer Fertigspritze 2. Binocrit 30.000 I.E./0,75 ml Injektionslösung in einer Fertigspritze |
|---|---|
| Marketing authorisation number(s) | 1. EU/1/07/410/048 2. EU/1/07/410/054 |
| CIP code | 1. (right:) 3902163 (false: 3902186) 2. (right:) 3902186 (false: 3902192) |
| Marketing authorisation holder | Sandoz GmbH |
| Batch number(s) | 1. (right:) 1911190118, expiry date 05/2021 (false: KF8616), 1907080054, expiry date 02/2021 2. (right:) 1906120007, expiry date 01/2021 (false: JY3731) |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-3253 |
