Database updated: 20 December 2024
Safety Information
Medsafe Online Recall Database
Detail of Recall
Type of Product: | Medicine |
Medsafe Reference: | 25236 |
Brand Name: | Avonex Pen |
Dose Form/Strength: | Solution for injection 30 mcg/0.5mL |
Affected: | |
Recalling Organisation: | Biogen NZ Biopharma Ltd Suite 35, Level 26, PWC Tower 188 Quay Street Auckland 1010 |
Contact Information: | |
Manufacturer: | Biogen Denmark Manufacturing ApS |
Issue: | Biogen NZ Biopharma Ltd is recalling one lot of Avonex Pen 30mcg in 0.5mL, solution for injection. The recall is due to a manufacturing issue that may have resulted in a potential loss of sterility. There is also the potential that the manufacturing issue may have weakened the glass structure of the syringe, compromising the structural integrity of the glass and/or resulting in the formation of particulate matter. |
Recall action type: | Recall |
Recall action: | Recall |
Level of recall: | Public Recall |
Date Commenced: | 25/10/2019 |
Additional Information: | www.medsafe.govt.nz/hot/RecallActionNoticesNew/25236.asp |