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