Published: 6 November 2019
Safety Information
Alert
Consumer level recall of one lot of Avonex Pen 30mcg in 0.5mL, Lot 1422362
6 November 2019
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.
Advice for consumers and caregivers
Information for healthcare professionals
Products affected
Further information
Useful links
Advice for consumers and caregivers
Do not use any Avonex Pens from the affected lot number. You can check any unused medicine you have on hand to see if it is from the affected lot, by checking as per the diagram below.
If you have Avonex Pens from the affected lot and have not been contacted about this issue, you should contact the pharmacy dispensing the product immediately.
Biogen NZ Biopharma Ltd can be reached at 0800 852 289 if you have any questions about the recall.
Consult your doctor if you have any concerns.
Report any adverse events by calling the Centre for Adverse Reactions Monitoring (CARM) toll-free at 0800 466 678 or by reporting online at https://nzphvc.otago.ac.nz/reporting/
Information for healthcare professionals
Avonex Pens from the affected lot were last distributed in April 2019.
Patients should be advised to stop using medicine from this lot immediately, and contact the pharmacy to arrange urgent replacement.
The product defect has the potential to affect the sterility of this medicine, which could lead to localised skin infections. In patients who are immunocompromised due to Multiple Sclerosis there is the potential for the localised infection to lead to systemic sepsis.
There have been no reports of adverse events reported to the company’s worldwide database as a result of this issue.
The company can be reached at 0800 853 289 if you have questions about this recall.
Any adverse events should be reported to the Centre for Adverse Reactions Monitoring (CARM) at https://nzphvc.otago.ac.nz/reporting/
Products affected
| Product name | Sponsor |
|---|---|
| Avonex Pen 30mcg in 0.5mL | Biogen NZ Biopharma Ltd |
Further information
Avonex Pens from the affected lot were distributed in New Zealand between October 2018 and April 2019 and have an expiry of 31 October 2020.
Useful links
