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

Biogen Idec UK is recalling batches as a precautionary measure due to a manufacturing issue.

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

Published 23 October 2019
Last updated 25 October 2019 + show all updates
  1. Correction of lot number for 4 x pre-filled pen
  2. Changed expiry date on 4 x pre-filled pen, 1423677, to 31 Oct 2020
  3. First published.