Kogenate Bayer Powder and Solvent for Solution for Injection - (CLDA (16)A/05)

Bayer is recalling the listed batches due to reduced potency of the active ingredient

Product information

CLDA number

CLDA (16)A/05

MDR number

MDR 84-07/16

Company name

Bayer

Product description

KOGENATE Bayer Powder and Solvent for Solution for Injection:

250 IU, EU/1/00/143/007

500 IU, EU/1/00/143/008

1000 IU, EU/1/00/143/009

2000 IU, EU/1/00/143/011

3000 IU, EU/1/00/143/012

Affected batches

Batch no Product Expiry date
KOGENATE BAYER 500 IU ITA2N65 12/06/2018
KOGENATE BAYER 500 IU ITA2CNV 19/03/2017
KOGENATE BAYER 500 IU ITA2P68 12/06/2018
KOGENATE BAYER 500 IU ITA2FLV 09/09/2017
KOGENATE BAYER 500 IU ITA2LI3 12/06/2018
KOGENATE BAYER 500 IU IITA2J0B 15/12/2017
KOGENATE BAYER 500 IU ITA28EP 08/09/2016
KOGENATE BAYER 500 IU ITA2J74 15/12/2017
KOGENATE BAYER 500 IU ITA2CI3 19/03/2017
KOGENATE BAYER 2000 IU ITA2FLN 17/09/2017
KOGENATE BAYER 2000 IU ITA2HZ2 25/12/2017
KOGENATE BAYER 2000 IU ITA2L0E 29/03/2018
KOGENATE BAYER 2000 IU ITA2N42 25/05/2018
KOGENATE BAYER 2000 IU ITA2NKJ 25/05/2018
KOGENATE BAYER 3000 IU ITA2KAH 23/05/2018
KOGENATE BAYER 3000 IU ITA27JE 15/08/2016
KOGENATE BAYER 3000 IU ITA295L 27/08/2016
KOGENATE BAYER 3000 IU ITA2KCJ 23/05/2018
KOGENATE BAYER 3000 IU ITA280Z 27/08/2016
KOGENATE BAYER 3000 IU ITA29EC 27/08/2016
KOGENATE BAYER 3000 IU ITA2JXJ 27/12/2017
KOGENATE BAYER 3000 IU ITA28K2 27/08/2016
KOGENATE BAYER 3000 IU ITA29S8 27/08/2016
KOGENATE BAYER 3000 IU ITA2BE9 05/03/2017
KOGENATE BAYER 3000 IU ITA2CH2 10/04/2017
KOGENATE BAYER 3000 IU ITA2DLA 10/04/2017
KOGENATE BAYER 3000 IU ITA2IZD 27/12/2017
KOGENATE BAYER 3000 IU ITA2F2U 06/09/2017
KOGENATE BAYER 1000 IU ITA28EF 23/09/2016
KOGENATE BAYER 1000 IU ITA2JXX 30/05/2018
KOGENATE BAYER 1000 IU ITA2D4I 28/06/2017
KOGENATE BAYER 250 IU ITA2NAJ 04/06/2018
KOGENATE BAYER 250 IU ITA2ENU 29/05/2017
KOGENATE BAYER 250 IU ITA2KVX 19/12/2017
KOGENATE BAYER 250 IU ITA2LHZ 19/12/2017
KOGENATE BAYER 250 IU ITA2BE8 11/03/2017
KOGENATE BAYER 250 IU ITA2J70 19/12/2017

Brief description of the problem

Recall because affected batches were manufactured with active ingredient that has either fallen below the potency specification since release to the market or is at risk of falling below specification prior to expiry.

Company contact for stock enquiries

Bayer Customer Services:
Tel 01635 563131

Email: orders-uk@bayer.co.uk

Company contact for medical information

Bayer Customer Services:
Tel 01635 563116

Email: Medical.Information@bayer.co.uk

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