Binocrit Injektionslösung in einer Fertigspritze New

Recall | Medicines | 29/07/2020

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
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