Question

Extended use beyond labelled expiry date

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