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  1. Safety & Availability (Biologics)

Voluntary Drug Recall Extension - Helixate FS

Voluntary Drug Recall Extension - Helixate FS

DATE RECALL INITIATED: August 10, 2016

MANUFACTURER:

Bayer HealthCare LLC
Berkeley, CA

REASON:

CSL Behring is issuing a follow-up to the communication sent to customers on July 21, 2016 regarding a voluntary recall of two lots of hemophilia A drug Helixate® FS containing active ingredient manufactured before November 2015. The lots communicated on July 21, 2016 are:

Product Lot Number NDC Number Expiry Date
HELIXATE FS 2000 IU 270R979 0053-8134-02 09/17/2017
HELIXATE FS 2000 IU 270TN1G 0053-8134-02 06/06/2018

An analysis was conducted of additional lots with active ingredient manufactured before November 2015 to determine if there was a need for further action. The analysis is now complete and, as a result, CSL Behring is voluntarily recalling additional lots.

Routine stability testing showed potency is declining faster than expected in these lots, which is why the recall is being conducted. The material is packaged in 5mL 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:

Product Lot Number NDC Number Expiry Date
HELIXATE FS 2000 IU 270PWG6 0053-8134-02 05/08/2017
HELIXATE FS 1000 IU 270NV9G 0053-8133-02 09/23/2016

For additional lots, potency may eventually fall below the pre-specified acceptable range before shelf life expiry. ("Additional Lots Subject to Recall").

Additional Lots Subject to Recall:

Product Lot Number NDC Number Expiry Date
HELIXATE FS 250 IU 270P892 0053-8131-02 09/15/2016
HELIXATE FS 250 IU 270PH46 0053-8131-02 11/18/2016
HELIXATE FS 250 IU 270P4NL 0053-8131-02 11/22/2016
HELIXATE FS 250 IU 270R5CH 0053-8131-02 05/29/2017
HELIXATE FS 250 IU 270R0LV 0053-8131-02 05/29/2017
HELIXATE FS 250 IU 270R7N5 0053-8131-02 08/13/2017
HELIXATE FS 250 IU 270RV8T 0053-8131-02 12/19/2017
HELIXATE FS 250 IU 270TGX1 0053-8131-02 02/07/2018
HELIXATE FS 500 IU 270NTPP 0053-8132-02 09/08/2016
HELIXATE FS 500 IU 270P8V6 0053-8132-02 11/07/2016
HELIXATE FS 500 IU 270R5K1 0053-8132-02 08/11/2017
HELIXATE FS 500 IU 270RR6J 0053-8132-02 08/27/2017
HELIXATE FS 500 IU 270RHG3 0053-8132-02 11/23/2017
HELIXATE FS 500 IU 270RTPX 0053-8132-02 12/15/2017
HELIXATE FS 500 IU 270T2T8 0053-8132-02 01/29/2018
HELIXATE FS 1000 IU 270P9CR 0053-8133-02 01/09/2017
HELIXATE FS 1000 IU 270RV9C 0053-8133-02 12/21/2017
HELIXATE FS 1000 IU 270T0R4 0053-8133-02 01/08/2018
HELIXATE FS 1000 IU 270T508 0053-8133-02 02/18/2018
HELIXATE FS 1000 IU 270TW0V 0053-8133-02 07/08/2018
HELIXATE FS 1000 IU 270V5P1 0053-8133-02 07/08/2018
HELIXATE FS 2000 IU 270NW81 0053-8134-02 10/02/2016
HELIXATE FS 2000 IU 270PCPX 0053-8134-02 02/09/2017
HELIXATE FS 2000 IU 270PP8N 0053-8134-02 02/09/2017
HELIXATE FS 2000 IU 270R0NN 0053-8134-02 06/12/2017
HELIXATE FS 2000 IU 270R53J 0053-8134-02 07/31/2017
HELIXATE FS 2000 IU 270R9HV 0053-8134-02 09/26/2017
HELIXATE FS 2000 IU 270RR1G 0053-8134-02 12/07/2017
HELIXATE FS 2000 IU 270T556 0053-8134-02 03/03/2018
HELIXATE FS 3000 IU 270NPV1 0053-8135-02 08/15/2016
HELIXATE FS 3000 IU 270NT1J 0053-8135-02 08/27/2016
HELIXATE FS 3000 IU 270PJ1G 0053-8135-02 03/05/2017
HELIXATE FS 3000 IU 270PP5C 0053-8135-02 04/10/2017
HELIXATE FS 3000 IU 270R83W 0053-8135-02 09/06/2017
HELIXATE FS 3000 IU 270RXCT 0053-8135-02 12/30/2017
HELIXATE FS 3000 IU 270T4G4 0053-8135-02 02/13/2018
HELIXATE FS 3000 IU 270TG53 0053-8135-02 03/27/2018
HELIXATE FS 3000 IU 270TGWJA 0053-8135-02 04/09/2018
HELIXATE FS 3000 IU 270TGWJ 0053-8135-02 04/09/2018
HELIXATE FS 3000 IU 270TTR7 0053-8135-02 06/22/2018

CSL Behring is asking customers to immediately quarantine inventory of the affected product under their direct control and to contact retail (pharmacy) level customers to have the identified product removed from pharmacy inventories and returned.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.