The following notice has been issued by the manufacturer:
Important safety information for patients using Jext® solution for injection in pre-filled pen.
We would like to alert you to a safety issue concerning some batches of Jext® 150 micrograms adrenaline auto-injector and Jext® 300 micrograms adrenaline auto-injector. The affected batches are listed below.
Routine testing conducted by ALK-Abelló has revealed that during the production process of the batches listed below the needle may have become bent, causing the needle to curl up inside the injector housing upon activation and consequently causing the pen not to deliver the required adrenaline dose. The malfunction only affects a small number, approximately 1 in 2500, of the pens in these batches. Immediate action has been taken to eliminate similar production issues in the future.
What you need to do
Check the batch number printed on the pen or the cardboard box to find out if your Jext® is affected:
If the batch number of your Jext® is not mentioned in the list below you should continue to carry and use your Jext® as normal for the emergency treatment of severe acute allergic reactions (anaphylaxis).
If the batch number of your Jext® is listed below you should obtain a replacement adrenaline auto-injector from your doctor as soon as this is practically possible. Continue to carry and use your Jext® as normal until you are able to obtain a replacement adrenaline auto-injector. You should ensure you understand how to use the replacement auto-injector correctly as it may be different from your Jext®.
If you suffer anaphylaxis before you have obtained a replacement adrenaline auto-injector from your doctor, you should use your Jext® as instructed by the prescribing doctor.
The safety of patients is our priority concern at ALK-Abelló and we are committed to delivering only high quality products. ALK-Abelló takesthe potential malfunction of some our adrenaline pens very seriously and has therefore immediately initiated a dialogue with the authorities regarding a recall. ALK-Abelló has also taken immediate action to eliminate similar production issues in the future. Please report any adverse events to ALK-Abelló on 0118 903 7940 or by e-mail at UKHUDrugSafety@alkabello.com
Adverse events should be reported via the MHRA Yellow Card Reporting Scheme. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard
For further information please visit http://www.jext.co.uk/drugalert or contact ALK-Abelló on 0800 028 3144 or info@uk.alk-abello.com
Batch number and expiry date of the Jext® batches recalled in the United Kingdom:
| Batch Number | Description | Expiry date |
| 0000907947 | Jext 150 µg | 30-04-2015 |
| 0000884202 | Jext 150 µg | 31-03-2015 |
| 0000862719 | Jext 150 µg | 28-02-2015 |
| 0000853456 | Jext 150 µg | 28-02-2015 |
| 0000890991 | Jext 150 µg | 28-02-2015 |
| 0000804924 | Jext 150 µg | 31-01-2015 |
| 0000785381 | Jext 150 µg | 31-01-2015 |
| 0000748008 | Jext 150 µg | 31-12-2014 |
| 0000900033 | Jext 300 µg | 30-04-2015 |
| 0000874587 | Jext 300 µg | 28-02-2015 |
| 0000858432 | Jext 300 µg | 28-02-2015 |
| 0000860701 | Jext 300 µg | 28-02-2015 |
| 0000837516 | Jext 300 µg | 28-02-2015 |
| 0000874585 | Jext 300 µg | 28-02-2015 |
| 0000829690 | Jext 300 µg | 31-01-2015 |
| 0000810356 | Jext 300 µg | 31-01-2015 |
| 0000800083 | Jext 300 µg | 31-01-2015 |
| 0000774775 | Jext 300 µg | 31-01-2015 |
| 0000780782 | Jext 300 µg | 31-01-2015 |
| 0000750808 | Jext 300 µg | 31-12-2014 |
| 0000733979 | Jext 300 µg | 31-12-2014 |
