IMPORTANT UPDATE
Extended Use-by Period for Specific Lots of EpiPen® 0.3mg Adrenaline Auto-Injectors
Extended Use Beyond Labelled Expiry Date for Specific Lots of EpiPen® 0.3mg Adrenaline Auto-Injectors
In August 2019, Mylan was granted approval to a variation to permanently extend the shelf life of EpiPen 0.3mg auto-injectors from 20 months to 24 months.
Mylan UK have obtained acceptance from the UK medicines regulator, MHRA, to extend the use of specific lot (batch) numbers of EpiPen® 0.3mg auto‐injectors already on the market, by 4 months beyond the labelled expiry date. The affected lot numbers are listed in the table below.
EpiPen® 0.3mg (single pack)
LOT | Labelled Expiry Date (end of the month) | Extended Use-by Date (end of the month) |
8FA092T | 09/2019 | 01/2020 |
8FA273E | 11/2019 | 03/2020 |
8KB332M | 02/2020 | 06/2020 |
8FA366K | 02/2020 | 06/2020 |
8FA367B | 02/2020 | 06/2020 |
8KB478B | 04/2020 | 08/2020 |
8KB474B | 04/2020 | 08/2020 |
8KB481B | 04/2020 | 08/2020 |
8KB510G | 05/2020 | 09/2020 |
8KB523G | 05/2020 | 09/2020 |
8KB648B | 06/2020 | 10/2020 |
8KB587B | 06/2020 | 10/2020 |
8KB630C | 06/2020 | 10/2020 |
8KB587F | 06/2020 | 10/2020 |
8KB671R | 07/2020 | 11/2020 |
9KB087B | 10/2020 | 02/2021 |
9KB148B | 10/2020 | 02/2021 |
9KB177AE | 11/2020 | 03/2021 |
9KB262B | 12/2020 | 04/2021 |
EpiPen® 0.3mg (twin pack)
LOT | Labelled Expiry Date (end of the month) | Extended Use-by Date (end of the month) |
8KB558C | 05/2020 | 09/2020 |
8KB630D | 06/2020 | 10/2020 |
8KB671F | 07/2020 | 11/2020 |
9KB148J | 10/2020 | 02/2021 |
9KB177E | 11/2020 | 03/2021 |
9KB252P | 11/2020 | 03/2021 |
9KB301J | 12/2020 | 04/2021 |
Important: the extended use only applies to the lots of EpiPen 0.3 mg auto-injectors listed above.
This extended use does not apply to EpiPen® 0.15mg Auto‐Injectors or any lot number of EpiPen 0.3 mg auto-injectors not specified. It is important that patients must continue to adhere to the labelled expiry date on any EpiPen® not covered by the lot numbers above.
Further information
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.
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.
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.
At the end of the extended use period (the end of the month listed under “Extended Use-by Date” in the table above), you will still need to obtain a new auto-injector by the usual means.
Please note that the information provided in this communication supersedes any other communication that patients receive from the Expiry Alert Service.
Contact Information
If you require additional information or have any questions, please see contact information section below.
EPI-2019-0269 DOP: September 2019