Buccolam Oromucosal Solution - possibility for chemical contamination

(ViroPharma SPRL) Pharmacists should quarantine batches and return them to original wholesaler for credit - class 2 action within 48 hours. (EL (14)A/12)

From:
Medicines and Healthcare products Regulatory Agency
Published
17 December 2014
Message type:
Medicines recall/notification
Medical specialty:
Pharmacy
Issued:
28 July 2014

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 

ViroPharma SPRL is recalling specific batches of Buccolam Oromucosal Solution, listed in the attached appendix, following a routine inspection of the company’s contract manufacturing site in the UK. 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. 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   30/09/2014       13/6/2013
1304071   30/11/2014       13/8/2013
1308017   31/12/2014       8/11/2013
1309008   28/02/2015       4/2/2014
1310011   28/02/2015       19/2/2014
1311027   30/04/2015       11/4/2014
1401040   30/04/2015       13/5/2014
1405019   30/06/2015       17/6/2014

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

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

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

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

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

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

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Published 17 December 2014
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