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

Medicines Healthcare Products Regulatory Agency

October 23
15:21 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 1423677 31 Oct 2010
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