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 |