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
Updates to this page
Published 11 August 2016