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CSL Behring has announced a voluntary recall of additional lots of Helixate FS with vial adapter. This is an update to the recall that was issued on July 25, 2016. All lot numbers affected by the July 25, 2016 recall and August 10, 2016 extension are:

Product

Lot Number

Expiration Date

Helixate FS 250 IU 270P892 09/15/2016
Helixate FS 250 IU 270PH46 11/18/2016
Helixate FS 250 IU 270P4NL 11/22/2016
Helixate FS 250 IU 270R5CH 05/29/2017
Helixate FS 250 IU 270R0LV 05/29/2017
Helixate FS 250 IU 270R7N5 08/13/2017
Helixate FS 250 IU 270RV8T 12/19/2017
Helixate FS 250 IU 270TGX1 02/07/2018
Helixate FS 500 IU 270NTPP 09/08/2016
Helixate FS 500 IU 270P8V6 11/07/2016
Helixate FS 500 IU 270R5K1 08/11/2017
Helixate FS 500 IU 270RR6J 08/27/2017
Helixate FS 500 IU 270RHG3 11/23/2017
Helixate FS 500 IU 270RTPX 12/15/2017
Helixate FS 500 IU 270T2T8 01/29/2018
Helixate FS 1000 IU 270P9CR 01/09/2017
Helixate FS 1000 IU 270RV9C 12/21/2017
Helixate FS 1000 IU 270T0R4 01/08/2018
Helixate FS 1000 IU 270T508 02/18/2018
Helixate FS 1000 IU 270TW0V 07/08/2018
Helixate FS 1000 IU 270V5P1 07/08/2018
Helixate FS 1000 IU 270NV9G 09/23/2016
Helixate FS 2000 IU 270NW81 10/02/2016
Helixate FS 2000 IU 270PCPX 02/09/2017
Helixate FS 2000 IU 270PP8N 02/09/2017
Helixate FS 2000 IU 270R0NN 06/12/2017
Helixate FS 2000 IU 270R53J 07/31/2017
Helixate FS 2000 IU 270R9HV 09/26/2017
Helixate FS 2000 IU 270RR1G 12/07/2017
Helixate FS 2000 IU 270T556 03/03/2018
Helixate FS 2000 IU 270R979 09/17/2017
Helixate FS 2000 IU 270TN1G 06/06/2018
Helixate FS 2000 IU 270PWG6 05/08/2017
Helixate FS 3000 IU 270NPV1 08/15/2016
Helixate FS 3000 IU 270NT1J 08/27/2016
Helixate FS 3000 IU 270PJ1G 03/05/2017
Helixate FS 3000 IU 270PP5C 04/10/2017
Helixate FS 3000 IU 270R83W 09/06/2017
Helixate FS 3000 IU 270RXCT 12/30/2017
Helixate FS 3000 IU 270T4G4 02/13/2018
Helixate FS 3000 IU 270TG53 03/27/2018
Helixate FS 3000 IU 270TGWJA 04/09/2018
Helixate FS 3000 IU 270TGWJ 04/09/2018
Helixate FS 3000 IU 270TTR7 06/22/2018
  • Recall Initiated on July 21, 2016
  • Recall Extended on August 10, 2016
  • Recall Extended on August 10, 2016 (Clarification provided by manufacturers on August 12, 2016 that these lot numbers are INCLUDED in recall extension dated August 10, 2016)

This is not an issue of safety of the product. Routine stability testing showed potency is declining faster than expected in these lots, which is why the recall is being conducted. For further information or to arrange for an exchange, please contact the CSL Behring Customer Service line at 1-800-683-1288 or customersupport@cslbehring.com.

CSL Behring will be engaging the Patient Notification System (PNS) to notify all registrants and is notifying customers. For those of you signed up with PNS, you will receive additional notification from PNS/SteriCycle, Inc.

Click here for the full notification from CSL Behring. 

 

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