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.