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)

LOTLabelled Expiry Date (end of the month)Extended Use-by Date(end of the month)
8FA092T09/201901/2020
8FA273E11/201903/2020
8KB332M02/202006/2020
8FA366K02/202006/2020
8FA367B02/202006/2020
8KB478B04/202008/2020
8KB474B04/202008/2020
8KB481B04/202008/2020
8KB510G05/202009/2020
8KB523G05/202009/2020
8KB648B06/202010/2020
8KB587B06/202010/2020
8KB630C06/202010/2020
8KB587F06/202010/2020
8KB671R07/202011/2020
9KB087B10/202002/2021
9KB148B10/202002/2021
9KB177AE11/202003/2021
9KB262B12/202004/2021

EpiPen® 0.3mg (twin pack)

LOTLabelled Expiry Date(end of the month)Extended Use-by Date (end of the month)
8KB558C05/202009/2020
8KB630D06/202010/2020
8KB671F07/202011/2020
9KB148J10/202002/2021
9KB177E11/202003/2021
9KB252P11/202003/2021
9KB301J12/202004/2021

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: info@mylan.co.uk