51茶馆

28 July 2014

Class 2 medicines recall

Action within 48 hours

Pharmacy, dispensing clinic and wholesale-level recall

MDR 40-03/14

Product details

ViroPharma SPRL

Buccolam Oromucosal Solution

(Midazolam Hydrochloride)

EU/1/11/709/001, EU/1/11/709/002, EU/1/11/709/003, EU/1/11/709/004

Alert details听

ViroPharma SPRL is recalling specific batches of Buccolam Oromucosal Solution, listed in the attached appendix, following a routine inspection of the company鈥檚 contract manufacturing site in the UK.听The inspection identified the possibility for chemical contamination. No evidence of contamination has been identified within Buccolam Oromucosal Solution on the market.

Replacement stocks of Buccolam are available.听Pharmacists are asked to quarantine any remaining stocks of the batches listed in the Appendix and return them to the original wholesaler for credit. For stock enquiries please contact UDG Customer Services on 01773 510123 or by email to Directtopharmacy@udg.co.uk.

For medical information enquires please contact Christopher Rains, ViroPharma SPRL Medical Information on 0800 7312801 or by email to uk.medinfo@viropharma.com.

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.

Appendix

Buccolam 2.5mg Oromucosal Solution
EU/1/11/709/001

Batch number		Expiry date		Pack size		First distributed
1304029	听	30/09/2014	听	听	听	13/6/2013
1304071	听	30/11/2014	听	听	听	13/8/2013
1308017	听	31/12/2014	听	听	听	8/11/2013
1309008	听	28/02/2015	听	听	听	4/2/2014
1310011	听	28/02/2015	听	听	听	19/2/2014
1311027	听	30/04/2015	听	听	听	11/4/2014
1401040	听	30/04/2015	听	听	听	13/5/2014
1405019	听	30/06/2015	听	听	听	17/6/2014

Buccolam 5mg Oromucosal Solution
EU/1/11/709/002

Batch number		Expiry date		Pack size		First distributed
1301060	听	31/08/2014	听	听	听	2/5/2013
1303014	听	30/09/2014	听	听	听	19/6/2013
1303016	听	31/10/2014	听	听	听	8/7/2013
1304028	听	30/11/2014	听	听	听	2/9/2013
1307034	听	31/10/2014	听	听	听	23/8/2013
1309024	听	31/01/2015	听	听	听	19/12/2013
1310001	听	31/12/2014	听	听	听	21/11/2013
1310012	听	31/03/2015	听	听	听	11/2/2014
1310056	听	30/04/2015	听	听	听	17/4/2014
1311054	听	30/04/2015	听	听	听	11/4/2014
1401002	听	30/06/2015	听	听	听	25/6/2014

Buccolam 7.5mg Oromucosal Solution
EU/1/11/709/003

Batch number		Expiry date		Pack size		First distributed
1302032	听	31/08/2014	听	听	听	21/5/2013
1303017	听	30/09/2014	听	听	听	26/6/2013
1304067	听	30/09/2014	听	听	听	10/9/2013
1306021	听	30/11/2014	听	听	听	16/9/2013
1307002	听	30/11/2014	听	听	听	20/9/2013
1307052	听	31/12/2014	听	听	听	1/10/2013
1309006	听	31/03/2015	听	听	听	1/11/2013
1310013	听	31/03/2015	听	听	听	31/1/2014
1311028	听	30/04/2015	听	听	听	12/3/2014
1311053	听	28/02/2015	听	听	听	7/1/2014
1311055	听	30/04/2015	听	听	听	10/4/2014
1312001	听	31/05/2015	听	听	听	22/5/2014
1405018	听	31/07/2015	听	听	听	24/6/2014

Buccolam 10mg Oromucosal Solution
EU/1/11/709/004

Batch number		Expiry date		Pack size		First distributed
1301043	听	31/07/2014	听	听	听	25/3/2013
1301057	听	31/08/2014	听	听	听	29/4/2013
1301058	听	31/08/2014	听	听	听	21/5/2013
1301079	听	31/08/2014	听	听	听	11/6/2013
1303015	听	30/09/2014	听	听	听	18/7/2013
1303020	听	30/11/2014	听	听	听	29/8/2013
1303021	听	31/12/2014	听	听	听	17/9/2013
1303022	听	31/08/2014	听	听	听	8/7/2013
1304026	听	31/12/2014	听	听	听	15/10/2013
1304027	听	30/09/2014	听	听	听	19/8/2013
1307032	听	31/01/2015	听	听	听	8/11/2013
1307033	听	31/01/2015	听	听	听	3/12/2013
1308015	听	31/01/2015	听	听	听	30/12/2013
1308016	听	31/01/2015	听	听	听	28/1/2014
1310014	听	31/03/2015	听	听	听	25/2/2014
1310040	听	31/03/2015	听	听	听	19/3/2014
1310053	听	28/02/2015	听	听	听	21/2/2014
1311025	听	30/04/2015	听	听	听	9/4/2014
1311052	听	30/04/2015	听	听	听	8/5/2014
1312007	听	31/05/2015	听	听	听	26/5/2014
1401034	听	30/06/2015	听	听	听	17/6/2014
1401069	听	31/07/2015	听	听	听	22/07/14

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