Kogenate Bayer
Recall
|
Medicines
|
11/08/2016
The marketing authorization holder informed its supplied customers in a letter dated August 10, 2016, that the above-mentioned batches of Kogenate®Bayer are being recalled. Stability data for these batches indicated a faster than usual decline in potency. Batches that no longer meet the potency specification and batches where there is a risk of the potency falling below the approved limit before the expiration date is reached are being recalled.
| Name of the medicinal product | Kogenate Bayer 250 IU; 500 IU; 2000 IU; 3000 IU |
|---|---|
| Marketing authorisation number(s) | EU/1/00/143/005 - 011; EU/1/00/143/013 |
| Marketing authorisation holder | Bayer Pharma AG |
| Batch number(s) | ITA28K9, ITA2AKP, ITA2BUD, ITA2EH9, ITA2EP0 ITA29P4, ITA29TL, ITA2C5S, ITA2F0F, ITA2HBL ITA29H3, ITA29TD, ITA2ACS, ITA2AKZ, ITA2B2H, ITA2C6R, ITA2FP0 ITA2IKH, ITA2LNT, ITA2NAB ITA2HP7, ITA2J0F, ITA2LZB, ITA2NAC ITA2KPA, ITA2L0T ITA2I4I, ITA2K5D, ITA2LZC, ITA2NSL, ITA2NZ0 ITA2I88 |
| Classification of the recall | 2 |
| BASG reference number | INS-640.001-1772 |
Further inquiry note
Page last modified:
12/07/2022