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

Date: August 11, 2016

CSL Behring is issuing a voluntary recall of two additional lots of Helixate FS. This email is a follow-up to the communication we sent last month regarding a voluntary recall of two lots of Helixate FS containing active ingredient manufactured before November 2015.

An analysis was conducted 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, CSL Behring is voluntarily recalling additional lots. The material is packaged in 5 mL glass vials and comes in a shelf carton with Sterile Water for Injection, USP, filter transfer set and package insert.

In two lots potency levels fell below the pre-specified acceptable range. These two lots are:

Helixate FS 2000 IU

Product

Lot Number

NDC Number

Expiry Date

Helixate FS 2000 IU

270PWG6

00053-8134-02

9/17/2017

Helixate FS 1000 IU

270NV9G

00053-8133-02

6/6/2018

For additional lots, potency may eventually fall below the pre-specified acceptable range before shelf life expiry. These lots are:

Product

Lot Number

NDC Number

Expiry Date

Helixate FS 250 IU

270P892

00053-8131-02

9/15/2016

Helixate FS 250 IU

270PH46

00053-8131-02

11/18/2016

Helixate FS 250 IU

270P4NL

00053-8131-02

11/22/2016

Helixate FS 250 IU

270R5CH

00053-8131-02

5/29/2017

Helixate FS 250 IU

270R0LV

00053-8131-02

5/29/2017

Helixate FS 250 IU

270R7N5

00053-8131-02

8/13/2017

Helixate FS 250 IU

270RV8T

00053-8131-02

12/19/2017

Helixate FS 250 IU

270TGX1

00053-8131-02

2/7/2018

Helixate FS 500 IU

270NTPP

00053-8132-02

9/8/2016

Helixate FS 500 IU

270P8V6

00053-8132-02

11/7/2016

Helixate FS 500 IU

270R5K1

00053-8132-02

8/11/2017

Helixate FS 500 IU

270RR6J

00053-8132-02

8/27/2017

Helixate FS 500 IU

270RHG3

00053-8132-02

11/23/2017

Helixate FS 500 IU

270RTPX

00053-8132-02

12/15/2017

Helixate FS 500 IU

270T2T8

00053-8132-02

1/29/2018

Helixate FS 1000 IU

270P9CR

00053-8133-02

1/9/2017

Helixate FS 1000 IU

270RV9C

00053-8133-02

12/21/2017

Helixate FS 1000 IU

270T0R4

00053-8133-02

1/8/2018

Helixate FS 1000 IU

270T508

00053-8133-02

2/18/2018

Helixate FS 1000 IU

270TW0V

00053-8133-02

7/8/2018

Helixate FS 1000 IU

270V5P1

00053-8133-02

7/8/2018

Helixate FS 2000 IU

270NW81

00053-8134-02

10/2/2016

Helixate FS 2000 IU

270PCPX

00053-8134-02

2/9/2017

Helixate FS 2000 IU

270PP8N

00053-8134-02

2/9/2017

Helixate FS 2000 IU

270R0NN

00053-8134-02

6/12/2017

Helixate FS 2000 IU

270R53J

00053-8134-02

7/31/2017

Helixate FS 2000 IU

270R9HV

00053-8134-02

9/26/2017

Helixate FS 2000 IU

270RR1G

00053-8134-02

12/7/2017

Helixate FS 2000 IU

270T556

00053-8134-02

3/3/2018

Helixate FS 3000 IU

270NPV1

00053-8135-02

8/15/2016

Helixate FS 3000 IU

270NT1J

00053-8135-02

8/27/2016

Helixate FS 3000 IU

270PJ1G

00053-8135-02

3/5/2017

Helixate FS 3000 IU

270PP5C

00053-8135-02

4/10/2017

Helixate FS 3000 IU

270R83W

00053-8135-02

9/6/2017

Helixate FS 3000 IU

270RXCT

00053-8135-02

12/30/2017

Helixate FS 3000 IU

270T4G4

00053-8135-02

2/13/2018

Helixate FS 3000 IU

270TG53

00053-8135-02

3/27/2018

Helixate FS 3000 IU

270TGWJA

00053-8135-02

4/9/2018

Helixate FS 3000 IU

270TGWJ

00053-8135-02

4/9/2018

Helixate FS 3000 IU

270TTR7

00053-8135-02

6/22/2018

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

Anyone with an existing inventory of Helixate 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 Helixate 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.