ALK-Abelló recalls some batches of Jext® adrenaline auto-injectors in the United Kingdom
ALK-Abelló is recalling certain batches of Jext®adrenaline auto-injector, 150 microgram and 300 microgram, at patient level in the UK. The class 2 recall affects 66,813 Jext® produced from March 2013 to October 2013. Please see the list of affected batches below.
Downloadable information for Doctors, Pharmacists and Patients
Jext® is a single-use adrenaline auto-injector intended for the emergency treatment of severe acute allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise induced anaphylaxis.
A routine testing conducted by ALK-Abelló has revealed that during the production process of these batches 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 percentage (0.04%) of the pens in these batches. Immediate action has been taken to eliminate similar production issues in the future.
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|
Patients are advised to check the batch number printed on the pen and the cardboard box to find out if their Jext® pen is affected by the recall:
Patients carrying a Jext® with a batch number not mentioned above can continue to carry their Jext® for emergency treatment of severe acute allergic reactions (anaphylaxis).
Advice to patients carrying a Jext® pen with one of the above-mentioned batch numbers
Patient carrying a Jext® with one of the above-mentioned batch numbers are advised to obtain a replacement adrenaline auto-injector from their doctor as soon as this is practically possible. Patients are advised to continue to carry and use their Jext® as normal until they are able to obtain a replacement adrenaline auto-injector. Patients should ensure they understand how to use the replacement auto-injector correctly as it may be different from Jext®.
If a patient suffers anaphylaxis before they have obtained a replacement adrenaline auto-injector from their health care professional, they are advised to use their 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 takes the potential malfunction of some our adrenalin 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.
ALK-Abelló is working with the Department of Health to minimise the financial consequences of this recall.
Jext® is a single-use adrenaline auto-injector and is indicated in the emergency treatment of severe acute allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise induced anaphylaxis. Jext® was developed by ALK-Abelló and approved in the United Kingdom in 2010. The product has been marketed since 2011. Jext® is produced in Europe by ALK-Abelló and subcontractors.
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