GovWire

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.

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