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 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.