Updated EpiPen® Statement - Extended Use Beyond Labelled Expiry Date
Extended Use Beyond Labelled Expiry Date for Specific Lots of EpiPen® 0.3mg Adrenaline Auto‐Injectors
Mylan UK have obtained acceptance from the MHRA to extend the use of specific lot numbers of EpiPen® 0.3mg auto‐injectors, by 4 months beyond the labelled expiry date.
The affected lot numbers are listed in the table below.
EpiPen® 0.3mg (single pack)
EpiPen® 0.3mg (twin pack)
Important: the extended use only applies to the lots of EpiPen® 0.3mg auto-injectors listed above. Patients can continue to use the EpiPen® 0.3mg auto-injectors of these specified lots safely until the extended use by date as stated above.
This extended use does not apply to EpiPen 0.15mg auto‐injectors or any lot number of EpiPen® 0.3mg auto-injectors not specified. Patients must continue to adhere to the labelled expiry date on any EpiPen not covered by the lot numbers above.
There has been an interruption in the supply of adrenaline auto-injectors in the UK. The overall market supply of adrenaline auto-injectors is being monitored by the Department of Health and Social Care.
To make sure patients can access their medicines during the supply shortage, the specific lots of EpiPen® 0.3mg auto-injectors (listed above) can be used 4 months beyond the labelled expiry date.
This 4-month extended use beyond the labelled expiry date for the specific lots listed above is based on supportive stability data for EpiPen® 0.3mg auto-injectors and has been reviewed by the MHRA. The EpiPen® 0.3mg auto-injectors of these specific lots will continue to work safely and as intended within the extended use by date. The EpiPen® auto-injectors should continue to be stored as labelled on the pack.
At the end of the extended use period (the end of the month listed under “Extended Use-by Date” in the table above), a new auto-injector will still need to be obtained.
You can find the lot number on the end‐flap of the box and on the EpiPen® itself. If you are unsure whether your EpiPen® is affected, talk to your pharmacist.
The information provided in this statement on the specific lot numbers listed above supersedes any other communication that patients may receive from the EpiPen® expiry alert service.
If you require additional information or have any questions, please contact,
Telephone: +44 (0)1707 853 000, Medical Information email: firstname.lastname@example.org