Ebixa 5mg/pump actuation 50ml and 100ml bottle - fault with some of the pump devices

(Lundbeck Limited) May result in suboptimal dosage of the product - class 2 action within 48 hours. (EL (14)A/19)

18 December 2014

Class 2 medicines recall

Action within 48 hours

Pharmacy-level recall

MDR 27-12/14

Product details

Lundbeck Limited

Ebixa 5mg/pump actuation 50ml bottle - EU/1/02/219/005

Ebixa 5mg/pump actuation 100ml bottle - EU/1/02/219/006

(Memantine hydrochloride)

Alert details

Lundbeck Limited is recalling specific batches of Ebixa 5mg/pump actuation 50ml and 100ml bottles, please see batch details in the Appendix. This is because of a fault with some of the pump devices which may result in suboptimal dosage of the product. We understand that no immediate or major hazard for the patient is expected however it cannot be excluded that individual patients may potentially experience worsening of their condition from under-dosage.

All remaining stock of the affected batches should be quarantined and returned to Alliance Healthcare Limited for credit. The only unaffected stock currently available is the 50ml bottle but Lundbeck Limited is working closely with its suppliers to bring stocks of 100ml bottles to the market as quickly as possible.

For enquiries relating to stock return, please call your local Alliance Healthcare Limited Local Service Centre Customer Services Team.

For medical information enquiries, please contact Lundbeck Medical Information, tel 01908 638972, email ukinfo@lundbeck.com, fax 01908 638935.

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.

Appendix

Batches of Ebixa 5mg/pump actuation being recalled

Ebixa 5 mg/pump actuation 50 ml bottle

Batch number Expiry date First distributed
363530 12.2016 17 Jun 2013
363729 12.2016 19 Jun 2013
364381 01.2017 09 Aug 2013
364620 02.2017 19 Aug 2013
364639 02.2017 23 Sep 2013
365766 07.2017 29 Oct 2013
366902 07.2017 22 Nov 2013
369095 09.2017 13 Jan 2014
370325 10.2017 15 May 201
471986 12.2017 24 Jul 2014
473236 03.2018 14 Sep 2014
474349 04.2018 03 Nov 2014

Ebixa 5 mg/pump actuation 100 ml bottle

Batch number Expiry date First distributed
364384 02.2017 06 Aug 2013
365579 04.2017 02 Sep 2013
366903 05.2017 31 Oct 2013
369090 09.2017 02 Jan 2014
370328 11.2017 07 Feb 2014
471112 01.2018 20 Mar 2014
471266 01.2018 02 May 2014
473233 02.2018 14 Jul 2014
474348 03.2018 25 Aug-2014
476354 04.2018 06 Nov 2014

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