Epipen 0.3mg Extended Use beyond labelled Expiry Date for Specific Lots
25th September 2019 IMPORTANT UPDATE
Extended use for specific lot numbers of EpiPen® 0.3mg Adrenaline Auto‐injectors.
This letter is sent in agreement with the UK medicines regulator, Medicines and Healthcare Products Regulatory Agency (MHRA), to inform you of the following:
Summary
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)
| 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® 0.3mg 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.
Further information on the extended use of the listed lots of EpiPen 0.3mg auto-injectors
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.
Further information on recommendations to professional bodies and patient support groups
- Tell patients and caregivers about the extended use-by date of the specified lots of EpiPen® 0.3mg auto-injectors as listed above. This does not apply to other lots of EpiPen® 0.3mg auto-injectors and does not apply to any of EpiPen® 0.15mg auto-injectors.
- Show patients and caregivers where to find the lot numbers on their device (on the end flap of the box and if necessary, on the EpiPen® itself) and encourage them to sign up for the Expiry Alert Service.
- Reassure patients and caregivers that their device will continue to work safely over the extended use period.
- Remind patients and caregivers that they should still obtain a new device at the end of the extended use period.
Please continue to report any adverse events. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
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: [email protected]