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Class 2 Medicines Recall (action within 48 hours): Jext 300 and 150 micrograms solution for injection in pre-filled pens - ALK-Abelló A/S (EL (13)A/28)

Document details:

Type: Drug Alert
Series No: EL (13)A/28
Audience: Healthcare professionals
Published: 9 December 2013
Format: Electronic
Size: A4
Pages: 2
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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DRUG ALERT

CLASS 2 MEDICINES RECALL

Action within 48 hours


Patient and pharmacy level recall

09 December 2013 EL (13)A/28 Our ref: 

MDR 12-11/13


Dear Healthcare Professional,

ALK-Abelló A/S

Jext 300 micrograms solution for injection in prefilled pen - PL 10085/0053

Jext 150 micrograms solution for injection in prefilled pen - PL 10085/0052

(Adrenaline Tartrate)

ALK-Abelló Ltd is recalling the above batches of Jext 300 and 150 micrograms solution for injection in pre-filled pens to patient level. This is because a potential problem with delivery of the dosage following activation of the auto injector has been identified. This could result in a failure to deliver any adrenaline tartrate in an emergency situation. The company has informed us that they have received no defect or ADR reports from the market which may be associated with this issue.

Recipients are asked to contact any patients who may be holding stock from the listed batches, which will have been dispensed after 8 May 2013, and advise them to make an appointment with their GP or clinic as soon as possible to discuss switching to an alternative product and any resulting training requirements. At present, the only alternative product available is Epipen. 

In order to ensure continuity of supply of Epipen, MHRA has approved the importation of some units of the product from the USA. These units are manufactured at the same site as and are identical to the UK approved product. They have been re-packaged with a UK carton and patient information leaflet. The label on the device itself is the original US label, however. The most significant difference between the labels is that ‘adrenaline’ is expressed as ‘epinephrine’ on the American inner labels. A letter to patients, explaining the situation, will be included in imported packs.  

Remaining stocks of the affected batches should be quarantined and returned to the original supplier. For stock return enquiries please contact your local Alliance Healthcare distribution centre.

For medical information or any other enquiries please contact ALK-Abelló Ltd on 0800 0283144.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.

Yours faithfully

Alison Bunce

Defective Medicines Report Centre
151 Buckingham Palace Road
London
SW1W 9SZ
Telephone +44 (0)20 3080 6574

Affected batches

Jext 300 micrograms solution for injection in pre-filled pen
 

Batch number Expiry date Pack size First distributed
0000733979 31 Dec 2014 1 x 1 09 May 2013
0000750808 31 Dec 2014 1 x 1 17 May 2013
0000774775 31 Jan 2015 1 x 1 05 June 2013
0000780782 31 Jan 2015 1 x 1 05 June 2013
0000800083 31 Jan 2015 1 x 1 25 June 2015
0000810356 31 Jan 2015 1 x 1 25 June 2013
0000829690 31 Jan 2015 1 x 1 15 July  2013
0000837516 28 Feb 2015 1 x 1 30 August 2013
0000858432 28 Feb 2015 1 x 1 02 August 2013
0000860701 28 Feb 2015 1 x 1 26 July 2013
0000874585 28 Feb 2015 1 x 1 23 August 2013
0000874587 28 Feb 2015 1 x 1 14 October 2013
0000900033 30 Apr 2015 1 x 1 16 September 2013


Jext 150 micrograms solution for injection in pre-filled pen
 

Batch number Expiry date Pack size First distributed
0000748008 31 Dec 2014 1 x 1 17 May 2013
0000785381 31 Jan 2015 1 x 1 19 Jun 2013
0000804924 31 Jan 2015 1 x 1 21 June 2013
0000853456 28 Feb 2015 1 x 1 26 July 2013
0000862719 28 Feb 2015 1 x 1 23 August 2013
0000884202 31 Mar 2015 1 x 1 06 September 2013
0000890991 28 Feb 2015 1 x 1 30 August 2013
0000907947 30 Apr 2015 1 x 1 16 September 2013

 

MHRA Distribution (further recipients by cascade): N/A
Page last modified: 09 December 2013