Voluntary Recall of Kogenate® FS - Additional Lots
Routine stability testing showed potency is declining faster than expected.

Date: August 12, 2016

Bayer is issuing a voluntary recall of additional lots of Kogenate FS. This email is a follow-up to the communication we sent last month regarding a voluntary recall of two lots of Kogenate FS 2000 IU with vial adapter.

Bayer has conducted an analysis of additional lots with active ingredient manufactured before November 2015 to determine if there was a need for further action. This analysis is now complete, as a result, Bayer is voluntarily recalling additional lots. The material is packaged in 5 mL glass vials and comes in a shelf carton with either a BIO-SET or vial adapter.

In two lots distributed between May 19, 2014 and February 23, 2015, potency levels fell below the pre-specified acceptable range. These two lots are:

Product

Lot Number

NDC Number

Expiry Date

Kogenate FS 2000 IU Vial Adapter

270PWG8

00026-3786-65

5/08/2017

Kogenate FS 3000 IU BIO-SET

270NPV2

00026-3797-70

8/17/2016

In eight lots distributed between June 9, 2015 and August 2, 2016, potency may eventually fall below the pre-specified acceptable range before shelf life expiry. These lots are:

Product

Lot Number

NDC Number

Expiry Date

Kogenate FS 250 IU Vial Adapter

270RV8X

00026-3782-25

12/19/2017

Kogenate FS 250 IU Vial Adapter

270TN10

00026-3782-25

06/04/2018

Kogenate FS 500 IU Vial Adapter

270R70V

00026-3783-35

08/27/2017

Kogenate FS 500 IU Vial Adapter

270RJ5L

00026-3783-35

11/23/2017

Kogenate FS 500 IU Vial Adapter

270T306

00026-3783-35

01/29/2018

Kogenate FS 500 IU Vial Adapter

270TG7L

00026-3783-35

03/25/2018

Kogenate FS 1000 IU Vial Adapter

270TW0R

00026-3785-55

07/8/2018

Kogenate FS 3000 IU Vial Adapter

270TTR6

00026-3787-75

06/22/2018

Kogenate FS IU Vial Adapter

Product

Lot Number

NDC Number

Expiry Date

Kogenate FS IU Vial Adapter

270R978

00026-3786-65

09/17/2017

Kogenate FS IU Vial Adapter

270TNIC

00026-3786-65

06/06/2018

Kogenate FS IU Vial Adapter

270PWG8

00026-3786-65

05/08/2017

Kogenate FS IU Vial Adapter

270NPY2

00026-3797-70

08/17/2016

Kogenate FS IU Vial Adapter

270RY8X

00026-3782-25

12/19/2017

Kogenate FS IU Vial Adapter

270TNI0

00026-3782-25

06/04/2018

Kogenate FS IU Vial Adapter

270R70V

00026-3783-35

08/27/2017

Kogenate FS IU Vial Adapter

270RJ5L

00026-3783-35

11/23/2017

Kogenate FS IU Vial Adapter

270T306

00026-3783-35

01/29/2018

Kogenate FS IU Vial Adapter

270TG7L

00026-3783-35

03/25/2018

Kogenate FS IU Vial Adapter

270TW0R

00026-3785-55

07/08/2018

Kogenate FS IU Vial Adapter

270TTR6

00026-3787-75

06/22/2018

It is important to note that based on all currently available and reviewed data that no safety observations or signals have been detected by Bayer's drug safety group and the current health risk assessment does not indicate an appreciable risk for patients for the affected lots.

Anyone with an existing inventory of Kogenate FS should determine whether they have product from the recalled lots, quarantine and discontinue distribution of this product.

Please contact our Wow! Customer Care team to complete the RGA process to return affected lot numbers of Kogenate FS to FFF.

If you had received notification and already returned the product to FFF, no action is required.

If you need assistance, please call FFF's
Wow! Customer Care at (800) 843-7477.