Question

EpiPen 0.3mg Adrenaline Auto-Injectors - Extended Use Beyond Labelled Expiry Date for Select Lots

To address supply constraints of EpiPen 0.3mg, Mylan UK has worked with the MHRA to obtain its approval to the use of nine specific lot (batch) numbers of EpiPen 0.3mg Auto-Injectors beyond the labelled expiry date by four months. The affected lot numbers are listed in the table below.

Patients should have confidence in using the products from these particular lots as Pfizer works to stabilize supply, which is anticipated in the fourth quarter of 2019.

This announcement is based on a careful review by Mylan and the MHRA of data about these specific batches provided by Pfizer. We believe the extension of the use of these nine batches beyond the labelled expiry date will temporarily improve patients’ access to and use of EpiPen 0.3mg Auto-Injectors.

The affected lots, which have labelled expiry dates between July 2018 and November 2018 are listed in the table below.

Lot

Labelled Expiry Date

(end of the month)

Extended Use by Date

(end of the month)

6FA794J

07.2018

11.2018

6FA795Y

07.2018

11.2018

7FA112F

09.2018

01.2019

7FA106B

09.2018

01.2019

7FA283B

10.2018

02.2019

7FA251D

10.2018

02.2019

7FA250B

10.2018

02.2019

7FA265C

11.2018

03.2019

7FA265B

11.2018

03.2019

 

Important: the extended use only applies to the lots of EpiPen 0.3mg auto-injectors listed in the table above.

The extension of the use beyond the labelled expiry date does not apply to EpiPen Jr 0.15mg auto-injectors or any EpiPen 0.3mg lot numbers not specified above. Patients must continue to adhere to the manufacturer’s expiry date labelled on any EpiPen not covered by the lot numbers above.

Further information

  • To make sure patients can access their medicines during this supply constraint, the period that the nine specific lots of EpiPen 0.3mg (listed above) can be used has been extended by a further four months beyond the labelled expiry date on the pack.
  • 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, please talk to your pharmacist.
  • This extension of use beyond the labelled expiry date is based on data showing these nine batches of EpiPen 0.3mg auto-injectors will work just as well for this period. This has been reviewed by the UK medicines regulator, MHRA.  EpiPen auto-injectors should continue to be stored as labelled on the pack.
  • As with all EpiPens, patients should periodically visually inspect the adrenaline solution through the viewing window to make sure the solution is clear and colourless. If it is discoloured or contains solid particles the EpiPen should be replaced as soon as possible.
  • At the end of the extended use beyond the labelled expiry date period (the end of the month listed in the right column above), you will still need to obtain a new auto-injector by the usual means.
  • Please note that the information provided in this letter supersedes any other communication that you may receive from the Expiry Alert Service.