Helixate NexGen - (CLDA (16)A/06)

CSL Behring is recalling the listed batches due to reduced potency of the active ingredient.

Product information

CLDA number

CLDA (16)A/06

MDR number

MDR 84-07/16

Company name

Marketing Authorisation Holder: Bayer

Distributor: CSL Behring

Product description

Helixate NexGen:

250 IU: EU/1/00/144/001

500 IU: EU/1/00/144/002

1000 IU: EU/1/00/144/003

2000 IU: EU/1/00/144/004

Batch number/expiry

Batch no Product Expiry date
270R0LTA HELIXATE NEXGEN FT 250IE GB 30/04/2017
270R0LTP HELIXATE NEXGEN FT 250IE GB 30/04/2017
270R0LTU HELIXATE NEXGEN FT 250IE GB 30/04/2017
270NTPNK HELIXATE NEXGEN FT 500IE GB 31/08/2016
270P411A HELIXATE NEXGEN FT 500IE GB 31/10/2016
270P8V5L HELIXATE NEXGEN FT 500IE GB 31/10/2016
270P8V5X HELIXATE NEXGEN FT 500IE GB 31/10/2016
270R54TE HELIXATE NEXGEN FT 500IE GB 31/07/2017
270RHG2L HELIXATE NEXGEN FT 500IE GB 31/10/2017
270RTR0A HELIXATE NEXGEN FT 500IE GB 30/11/2017
270RTR0F HELIXATE NEXGEN FT 500IE GB 30/11/2017
270NV98E HELIXATE NEXGEN FT 1000IE GB 31/08/2016
270P9CLL HELIXATE NEXGEN FT 1000IE GB 31/12/2016
270R1C6C HELIXATE NEXGEN FT 1000IE GB 31/05/2017
270R1C6L HELIXATE NEXGEN FT 1000IE GB 31/05/2017
270R1C6N HELIXATE NEXGEN FT 1000IE GB 31/05/2017
270TN0RN HELIXATE NEXGEN FT 1000IE GB 30/04/2018
270PCR0B HELIXATE NEXGEN FT 2000IE GB 31/01/2017
270PCR0N HELIXATE NEXGEN FT 2000IE GB 31/01/2017
270PWG7E HELIXATE NEXGEN FT 2000IE GB 31/03/2017
270R0NPJ HELIXATE NEXGEN FT 2000IE GB 31/05/2017
270R53HF HELIXATE NEXGEN FT 2000IE GB 31/07/2017
270R53HM HELIXATE NEXGEN FT 2000IE GB 31/07/2017
270R977H HELIXATE NEXGEN FT 2000IE GB 31/08/2017
270R9HPB HELIXATE NEXGEN FT 2000IE GB 31/08/2017
270R9HPK HELIXATE NEXGEN FT 2000IE GB 31/08/2017
270RW8TH HELIXATE NEXGEN FT 2000IE GB 30/11/2017
270RW8TR HELIXATE NEXGEN FT 2000IE GB 30/11/2017
270TGK3B HELIXATE NEXGEN FT 2000IE GB 28/02/2018

Brief description of the problem

Recall because affected batches were manufactured with active ingredient that has either fallen below the potency specification since release to the market or is at risk of falling below specification prior to expiry.

Company contact for stock enquiries

CSL Behring Customer Services:
Tel: 01444 447402 / 422

Email: customerservicesuk@cslbehring.com

Company contact for medical information enquiries

CSL Behring Medical Information:
Tel: 01444 447405

Email: medinfo@cslbehring.com

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