Buccolam recalled over contamination fears
Manufacturer ViroPharma SPRL is recalling batches of Buccolam Oromucosal solution over fears they could be contaminated
Manufacturer ViroPharma SPRL is recalling batches of Buccolam oromucosal solution over fears they could be contaminated.
A routine inspection of the company's UK manufacturing site had identified a possible risk of chemical contamination, the MHRA said yesterday (July 28). However, no evidence of contamination had been found in batches of the seizure medication already on the market, it said.
The medicines watchdog urged pharmacists to quarantine any remaining stock of affected batches and return it to their wholesaler for credit. Replacement stocks of Buccolam (midazolam) were available, the MHRA added.
For stock enquiries, contact Michelle Barber from distributor UDG on 01773 515124 or email [email protected]. For medical enquiries, contact Christopher Rains from ViroPharma SPRL on 0800 7312801 or by email at [email protected].
The affected batches are:
Buccolam 2.5mg oromucosal solution EU/1/11/709/001
|
Batch number |
Expiry date |
First distributed |
|
1304029 |
September 30, 2014 |
June 13, 2013 |
|
1304071 |
November 30, 2014 |
August 13, 2013 |
|
1308017 |
December 31, 2014 |
November 8, 2013 |
|
1309008 |
February 28, 2015 |
February 4, 2014 |
|
1310011 |
February 28, 2015 |
February 19, 2014 |
|
1311027 |
April 30, 2015 |
April 11, 2014 |
|
1401040 |
April 30, 2015 |
May 13, 2014 |
|
1405019 |
June 30, 2015 |
June 17, 2014 |
Buccolam 5mg oromucosal solution EU/1/11/709/002
|
Batch Number |
Expiry Date |
First Distributed |
|
1301060 |
August 31, 2014 |
May 2, 2013 |
|
1303014 |
September 30, 2014 |
June 19, 2013 |
|
1303016 |
October 31, 2014 |
July 8, 2013 |
|
1304028 |
November 30, 2014 |
September 2, 2013 |
|
1307034 |
October 31, 2014 |
August 23, 2013 |
|
1309024 |
January 31, 2015 |
December 19, 2013 |
|
1310001 |
December 31, 2014 |
November 21, 2013 |
|
1310012 |
March 31, 2015 |
February 11, 2014 |
|
1310056 |
April 30, 2015 |
April 17, 2014 |
|
1311054 |
April 30, 2015 |
April 11, 2014 |
|
1401002 |
June 30, 2015 |
June 25, 2014 |
Buccolam 7.5mg oromucosal solution EU/1/11/709/003
|
Batch number |
Expiry date |
First distributed |
|
1302032 |
August 31, 2014 |
May 21, 2013 |
|
1303017 |
September 30, 2014 |
June 26, 2013 |
|
1304067 |
September 30, 2014 |
September 10, 2013 |
|
1306021 |
November 30, 2014 |
September 16, 2013 |
|
1307002 |
November 30, 2014 |
September 20, 2013 |
|
1307052 |
December 31, 2014 |
October 1, 2013 |
|
1309006 |
March 31, 2015 |
November 1, 2013 |
|
1310013 |
March 31, 2015 |
January 31, 2014 |
|
1311028 |
April 30, 2015 |
March 12, 2014 |
|
1311053 |
February 28, 2015 |
January 7, 2014 |
|
1311055 |
April 30, 2015 |
April 10, 2014 |
|
1312001 |
May 31, 2015 |
May 22, 2014 |
|
1405018 |
July 31, 2015 |
June 24, 2014 |
Buccolam 10mg oromucosal solution EU/1/11/709/004
|
Batch number |
Expiry date |
First distributed |
|
1301043 |
July 31, 2014 |
March 25, 2013 |
|
1301057 |
August 31, 2014 |
April 29, 2013 |
|
1301058 |
August 31, 2014 |
May 21, 2013 |
|
1301079 |
August 31, 2014 |
June 11, 2013 |
|
1303015 |
September 30, 2014 |
July 18, 2013 |
|
1303020 |
November 30, 2014 |
August 29, 2013 |
|
1303021 |
December 31, 2014 |
September 17, 2013 |
|
1303022 |
August 31, 2014 |
July 8, 2013 |
|
1304026 |
December 31, 2014 |
October 15, 2013 |
|
1304027 |
September 30, 2014 |
August 19, 2013 |
|
1307032 |
January 31, 2015 |
November 8, 2013 |
|
1307033 |
January 31, 2015 |
December 3, 2013 |
|
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