Medical safety alert

Jext 300 and 150 micrograms solution for injection in pre-filled pens - problem with delivery of dosage

(ALK-Abelló A/S) Potential problem with delivery of dosage following activation of auto injector. Class 2 action within 48 hours (EL (13)A/28)

09 December 2013

Class 2 medicines recall

Action within 48 hours

Patient and pharmacy-level recall

MDR 12-11/13

Product details

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)

Alert details

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.

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

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