Question

Extended Expiration Dates for Specific Lots of EpiPen® 0.3mg Adrenaline Auto-Injectors

In August 2019, the MHRA granted approval for Mylan UK to permanently extend the shelf life of EpiPen 0.3mg auto-injectors from 20 months to 24 months.

For AAIs already on the market, prior to the permanent extension of shelf life above, Mylan UK obtained approval from the MHRA to extend the use of specific lot (batch) numbers of EpiPen® 0.3mg auto‐injectors, 4 months beyond the labelled expiry date. The affected lot numbers are listed in the table below.

This batch-specific extended use does not apply to EpiPen® 0.15mg AAI 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 below.

 

EpiPen® 0.3mg (single pack)

LOT

   

Original Expiry Date

 Extended Expiry Date

   

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

Further information

You can find the lot number on the end-flap of the box and on the EpiPen® itself. If you’re 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 Expiry 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.