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.

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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.