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Company led drug alert – Avonex 30 micrograms/0.5ml Solution for Injection

Read the official alert on GOV.UK — MedRegWatch re-presents it; GOV.UK is the authoritative source.

TypeMedicines recall/notification
Issued23 Oct 2019

CLDA Number

CLDA (19)A/06

MDR Number

MDR 57-10/19

Company name

Biogen Idec UK

Product description

Avonex 30 micrograms/0.5ml Solution for Injection

  • 4 x pre-filled pen, EU/1/97/033/004
  • 12 x pre-filled pen, EU/1/97/033/005
  • 4 x pre-filled syringe, EU/1/97/033/006

Batch Number/ Expiry

Product Lot number Expiry Date
4 x pre-filled pen   1423675   31 Oct 2020
12 x pre-filled pen   1423676   31 Oct 2020
4 x pre-filled syringes   1423350   31 Oct 2020

Brief Description of Problem

As a precautionary measure, Biogen Idec UK Limited is recalling the above lots to wholesaler, pharmacy and homecare provider level due to a manufacturing issue which could potentially have resulted in a loss of sterility assurance and may have weakened the glass structure of the syringe with the possible formation of particulate matter.

Company Contact for medical information enquiries

For medical information enquiries, please contact: MedInfoUKI@biogen.com

For stock enquiries, please contact:Distribution-UK@biogen.com

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