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
Published 11 August 2016